Senior RA Specialist

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Copenhagen

Job Description:

DePuy Synthes is recruiting for a Senior RA Specialist, located in Copenhagen, Denmark.

Purpose/General summary

E nsuring compliance with Medical Device regulations, related legislation, standards, etc.

H aving ex pertise in local and EU regulatory requirements for Medical Devices and Drugs .

Key responsibilities include managing projects and activities related to the assessment and maintenance of regulatory systems, effectively communicating with key stakeholders, and analyzing regulatory guidelines

Duties & Responsibilities



* Ensure Regulatory Compliance of Medical Devices (MD) facilitating local markets access ( Sweden, Finland, Denmark, Norway, Iceland ) for the full product life cycle - Compliance with both local country requirements and the EU MDR.



* Provide strategic guidance to the commercial organization related to regulatory requirements and develops recommendations pertinent to the local or bigger business in accordance with local and EU regulations and relevant guidelines.



* Provide advice, counsel, and expertise on RA issues, both proactively and reactively.



* Represent the local market and its requirements in various internal forums and stakeholders, including the commercial, regional and global base business organizations.



* Represent J&J in various internal and external forums such as Trade Associations, meetings with local Health Authorities, etc.



* Demonstrate deep domain expertise in the regulatory requirements for local and EU registrations, licensing and other RA compliance related matters.



* Partners closely with internal stakeholders across Johnson & Johnson ( e.g.

local commercial organization, central and regional strategy teams) to ensure that the compliance-related requirements are evaluated and executed within the local commercial launch plan strategies.

The same applies for product modifications.



* Analyze, interpret, and synthesize regulations and guidelines, and provide clear and timely communicati...