30 days old

Project Manager I, RA

Aesculap Implant Systems
Center Valley, PA 18034
  • Job Code
    115444853
Aesculap Implant Systems


Project Manager I, RA

US-PA-Center Valley

Job ID: 2019-15493
Type: Regular Full-Time
# of Openings: 1
Category: Regulatory
Aesculap Implant Systems

Overview

Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives.



Responsibilities

Position Summary:

The Project Manager I, Regulatory Affairs is primarily responsible for multiple product development projects, and potentially multiple product development programs, from the Regulatory Affairs perspective. Responsible for obtaining and maintaining AIC and AIS product registrations, clearances and approvals through the US Food and Drug Administration (FDA). In this pursuit, the department manages projects and proactively work with Marketing, Research and Development (R&D), Medical and Scientific Affairs (MSA), and other cross-functional groups throughout the product development process. Regulatory Affairs plays a critical role in Product Life Cycle Management (PLM), from concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the US Food and Drug Administration, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector.

Principal Duties Responsibilities:

  • Serves as Regulatory Affairs lead on cross-functional product development project teams.
  • Works with Marketing, R&D, MSA and QA to develop effective regulatory strategies.
  • Facilitates the generation and provision of information for product submissions, and helps to drive the product development process.
  • Reviews information (e.g. plans, protocols, reports) for suitability for submission.
  • Drafts Letters-to-File, 510(k), De Novo, IDE and PMA submissions.
  • Directly interacts and negotiates with FDA to ensure product clearances/approvals.
  • Ensures the timely registration/clearance/approval of products.
  • Resolves regulatory issues and develops solutions to a variety of problems of critical scope and complexity with little or no supervision.
  • Supports post-approval activities.
  • Reviews and approves labeling, packaging, advertising and promotional information for regulatory compliance.
  • Provide regulatory input for product recalls and recall strategies.
  • Anticipates regulatory obstacles and emerging issues throughout the product life-cycle and develops solutions with other departments.
  • Actively participates in various industry groups (e.g. AdvaMed, OSMA, AAMI).
  • Keeps abreast of and shares information of changes to the regulatory and competitive environment.
  • Interacts with FDA, industry groups (e.g. AdvaMed, OSMA), corporate partners, customers and vendors.
  • Assists RA staff and cross-functional teams to aid in the development of Regulatory strategies to ensure timely product registrations, approvals and clearances.
  • Reviews submissions to the FDA.
  • Manages and disseminates Regulatory Intelligence and training to RA staff and other stakeholders.
  • Oversees the review of product labeling, packaging, advertising and promotional information.
  • Assists Quality Assurance with FDA inspections and internal/ external audits.
  • Must comply with applicable regulations, as stated in Quality Manual.
  • Must embody the Company’s Vision, Mission and Values.
  • Other duties as assigned.

Secondary / peripheral job functions:

  • Supports the Head of Regulatory Affairs, as required / when requested.
  • Performs other duties or special projects as assigned by Regulatory Affairs Management/Leadership.
  • Requires excellent written, oral and interpersonal communication skills.
  • Computer skills in Windows, MS Word, Excel and Power Point.
  • Must be able to travel by automobile, train and airplane, and work occasional weekends.

Supervisory Responsibilities:

  • No direct supervisory responsibility. Provides coaching and mentoring to junior staff.
  • May work in a supervisory role during absence of the Head of Regulatory Affairs.

Job Specifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.



Qualifications

Education/Experience:

  • Bachelor of Science Degree in Engineering or Life Science -or- Associate of Science Degree Plus Significant Medical Device Regulatory Affairs Experience
  • Minimum of 10 years of Regulatory Affairs experience in an FDA-regulated industry. Medical device industry experience highly preferred.
  • Substantial experience directly interacting with the US FDA (e.g. meetings, negotiations).
  • Practical knowledge of product development, product life cycle management, and design controls, medical device registration/clearance/approval, QSR and GMP desired.
  • Practical experience with testing (e.g. bench testing, biocompatibility testing, etc.), spine and/or orthopedics desired.
  • Regulatory Affairs Certification a plus. Project Management Certification a plus.
  • Ability to anticipate changing regulations and business needs, and proactively work to change direction.
  • Strong technical understanding of products, procedures, practices and associated medical terminology.
  • Proficient in MS Office Suite. SAP experience preferred.
  • Must be able to travel locally, domestically and internationally.

Language and mathematical skills; reasoning ability:

  • Language Skills: Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies and/or members of the business community. Ability to effectively present information to executive management, public groups and/or boards of directors.
  • Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Reasoning Ability: Ability to define problems, collect date, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com..

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PI115444853

<b>Aesculap Implant Systems</b><br/><br/><br/><b>Project Manager I, RA</b><br/><br/>US-PA-Center Valley<br/><br/><b>Job ID:</b> 2019-15493<br/><b>Type:</b> Regular Full-Time<br/><b># of Openings:</b> 1<br/><b>Category:</b> Regulatory<br/>Aesculap Implant Systems<br/><br/><b>Overview</b><br/><br/><p style="margin-bottom: .0001pt;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients lives.</span></p><br/><br/><b>Responsibilities</b><br/><br/><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Position Summary: </strong></span></p><p style="margin: 0cm -1.1pt .0001pt 0cm;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p><p style="margin: 0in 0in 0pt;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">The Project Manager I, Regulatory Affairs is primarily responsible for multiple product development projects, and potentially multiple product development programs, from the Regulatory Affairs perspective. Responsible for obtaining and maintaining AIC and AIS product registrations, clearances and approvals through the US Food and Drug Administration (FDA). In this pursuit, the department manages projects and proactively work with Marketing, Research and Development (R&D), Medical and Scientific Affairs (MSA), and other cross-functional groups throughout the product development process. Regulatory Affairs plays a critical role in Product Life Cycle Management (PLM), from concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the US Food and Drug Administration, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Principal Duties Responsibilities:</strong></span></p><ul><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Serves as Regulatory Affairs lead on cross-functional product development project teams.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Works with Marketing, R&D, MSA and QA to develop effective regulatory strategies.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Facilitates the generation and provision of information for product submissions, and helps to drive the product development process.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Reviews information (e.g. plans, protocols, reports) for suitability for submission.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Drafts Letters-to-File, 510(k), De Novo, IDE and PMA submissions.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Directly interacts and negotiates with FDA to ensure product clearances/approvals.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Ensures the timely registration/clearance/approval of products.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Resolves regulatory issues and develops solutions to a variety of problems of critical scope and complexity with little or no supervision.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Supports post-approval activities.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Reviews and approves labeling, packaging, advertising and promotional information for regulatory compliance.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Provide regulatory input for product recalls and recall strategies.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Anticipates regulatory obstacles and emerging issues throughout the product life-cycle and develops solutions with other departments.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Actively participates in various industry groups (e.g. AdvaMed, OSMA, AAMI).</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Keeps abreast of and shares information of changes to the regulatory and competitive environment.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Interacts with FDA, industry groups (e.g. AdvaMed, OSMA), corporate partners, customers and vendors.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Assists RA staff and cross-functional teams to aid in the development of Regulatory strategies to ensure timely product registrations, approvals and clearances.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Reviews submissions to the FDA.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Manages and disseminates Regulatory Intelligence and training to RA staff and other stakeholders.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Oversees the review of product labeling, packaging, advertising and promotional information.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Assists Quality Assurance with FDA inspections and internal/ external audits.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Must comply with applicable regulations, as stated in Quality Manual.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Must embody the Companys Vision, Mission and Values.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Other duties as assigned.</span></li></ul><p style="margin-right: -1.1pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"> </span></p><p style="margin-right: -1.1pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Secondary / peripheral job functions:</strong></span></p><ul><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Supports the Head of Regulatory Affairs, as required / when requested.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Performs other duties or special projects as assigned by Regulatory Affairs Management/Leadership.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Requires excellent written, oral and interpersonal communication skills.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Computer skills in Windows, MS Word, Excel and Power Point.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Must be able to travel by automobile, train and airplane, and work occasional weekends.</span></li></ul><p style="margin-right: -1.1pt;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p><p style="margin-right: -1.1pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Supervisory Responsibilities:</strong></span></p><ul><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">No direct supervisory responsibility. <span style="color: black;">Provides coaching and mentoring to junior staff.</span></span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">May work in a supervisory role during absence of the Head of Regulatory Affairs.</span></li></ul><p style="margin-right: -1.1pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"> </span></p><p style="border: none; padding: 0in;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Job Specifications:</strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.</span></p><br/><br/><b>Qualifications</b><br/><br/><p style="margin-right: -1.1pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Education/Experience: </strong></span></p><ul><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Bachelor of Science Degree in Engineering or Life Science -or- Associate of Science Degree Plus Significant Medical Device Regulatory Affairs Experience</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Minimum of 10 years of Regulatory Affairs experience in an FDA-regulated industry. Medical device industry experience highly preferred.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Substantial experience directly interacting with the US FDA (e.g. meetings, negotiations).</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Practical knowledge of product development, product life cycle management, and design controls, medical device registration/clearance/approval, QSR and GMP desired.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Practical experience with testing (e.g. bench testing, biocompatibility testing, etc.), spine and/or orthopedics desired. </span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Regulatory Affairs Certification a plus. Project Management Certification a plus.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Ability to anticipate changing regulations and business needs, and proactively work to change direction.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Strong technical understanding of products, procedures, practices and associated medical terminology.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Proficient in MS Office Suite. SAP experience preferred.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">Must be able to travel locally, domestically and internationally.</span></li></ul><p style="margin-right: -1.1pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Language and mathematical skills; reasoning ability:</strong></span></p><ul><li><span style="font-family: calibri, sans-serif; font-size: 12pt;"><span style="text-decoration: underline;">Language Skills:</span> Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies and/or members of the business community. Ability to effectively present information to executive management, public groups and/or boards of directors.</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;"><span style="text-decoration: underline;">Mathematical Skills:</span> Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. </span></li><li><span style="font-family: calibri,sans-serif; font-size: 12pt;"><span style="text-decoration: underline;">Reasoning Ability:</span> Ability to define problems, collect date, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. </span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;">While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.</span></p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;"> </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;">B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com..</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;">Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.</span></p><br/><br/>All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. <img src="https://analytics.click2apply.net/v/RDVJRDcEj847tPbefPQNq"> <p>PI115444853</p>

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Posted: 2019-11-13 Expires: 2019-12-14

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Project Manager I, RA

Aesculap Implant Systems
Center Valley, PA 18034

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