7 days old

Regulatory Affairs Manager

GE Energy
Danderyd, Stockholms län 182 33
Role Summary:In the role as Regulatory Affairs Manager you will be responsible for the National Regulatory Affairs processes for our business in Sweden. This includes responsibility for all regulatory activities that supports the compliance, registration, maintenance and promotion of GE Healthcare products in the country, as well as acting as national Pharmacovigilance and Responsible Person for the wholesaler license.

Essential Responsibilities:

+ Main regulatory point of contact with national regulatory authorities on behalf of GE Healthcare

+ Responsible Person for the wholesaler license (GDP)

+ Local Pharmacovigilance person supporting central PV

+ Responsible for ensuring local regulatory compliance and maintenance for GE Healthcare products

+ Responsible person for the review and approval of promotional material in local market

+ Responsible for providing regulatory support to commercial business priorities

+ Responsible for preparing, maintaining and reviewing local Quality Management System including training and internal audit locally in accordance with GxP and local SOPs

+ Comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position

+ Complete Quality & Compliance training within the defined deadlines

+ Proactive in assessing impact of new regulations in local market

+ Provide national regulatory support as requested in relation to authority inspections

+ Provide national regulatory input and approval related to Change Control processes for artwork.

In this position you will report to the Regulatory Affairs EU & EAGM Region Lead. Locally, you will be part of a small commercial team


+ Bachelors Degree, preferably within pharmaceutical sciences, and minimum significant years of regulatory affairs experience from the medical device or pharmaceutical industry or with medical product regulatory agencies, with experience in dealing directly with regulatory authorities

+ Ability to prioritize, plan and evaluate deliverables

+ Ability to work independently with minimal daily supervision on projects and activities

+ Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner

+ Fluent in Swedish

+ Experience using spreadsheet and presentation software

Desired Characteristics:

+ Ability to interact with, lead and work with multiple functions/stakeholders

+ Team and business oriented collaborate with others to solve business problems

+ Clear thinker and flexible

+ Strong PC-skills

Please apply via www.ge.com/careers no later than Feb. 22nd.

About Us:GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. Learn More About GE Healthcare.

GE is committed to taking on the worlds toughest challenges. In order to fulfill that promise we rely on a culture of leadership, diversity and inclusiveness. We aim to employ the worlds brightest minds to help us create a limitless source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and stylespeople like you!

Become a fan of our Facebook page. Receive job and event notifications by becoming a member of the GE Talent Community. Stay up to date on whats happening at GE around the globe by checking out the GE Careers Blog.

Additional Locations:Sweden;Danderyd;


Posted: 2020-02-11 Expires: 2020-03-12

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Regulatory Affairs Manager

GE Energy
Danderyd, Stockholms län 182 33

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