Senior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | Quality
Role: Executive Director / VP Divisional Regulatory Affairs
The company:
This is an exciting position to join a world leader at the forefront of healthcare innovation. With over 50,000 employees worldwide, the Regulatory Senior Director will be THE leader for all divisional regulatory matters for a major division of the company worldwide.
This is a multi-site, multi-region and multi-layered responsibility with a divisional/business unit focus. The team size is approx. 40+ people covering various responsibilities in regulatory affairs including:
Premarket support to product development
Full product lifecycle management responsibility
New product introductions
Global RA strategy across your product portfolio
Post market regulatory activities
Your direct reports will be directors and associate directors. This is a position with a high level of exposure and influence within the company, and reports directly into a member of the senior leadership team, with a strong collaboration with the divisional President.
As the Executive Director Regulatory Affairs, you will:
Formulate the regulatory strategy for the division, developing departmental budgets, and representing the RA department in company projects
Harmonize regulatory strategies with business goals and execute strategic plans effectively across the organisation
Lead a department of approx. 40 regulatory staff in multiple countries across Europe and the US
Develop and manage upcoming leaders to improve overall performance
Provide guidance on regulatory changes and opportunities to legal teams and executive management
Establish RA policy and best practices and ensure compliance to them
Develop regulatory strategies for the maintenance and new product introduction of medical devices into these markets
Act as the voice of the business in discussions with global regulatory agencies; empower team members to engage and negotiate confidently
Your internal partners will be regional and business unit leaders
Your role will be to foster strong collaborative relationships with these partners in order to achieve business objectives
Establish best practices for regulatory activities and ensure consistent application across all stages of the product regulatory lifecycle
We are looking for successful regulatory professionals with a proven track record leading in MATRIX organizations.
If you are excited by the prospect of working in a multifaceted environment and able to build successful working relationships with both internal and external partners, this could be a great career step for you!
To be an Executive Director Regulatory Affairs, you will bring ideally:
Degree in Lifesciences or Engineering
Experience interacting with the US FDA
10 years working experience in medical devices
Premarket regulatory experience with active medical devices
Multi-layer management experience (managing managers)
Strong working knowledge of ISO 13485, QSR, MDR, MDD
Ability to build relationships with other areas of the organization and influence
Interested to explore this further? Please send your CV to Frankie@elemed.eu to arrange a confidential career discussion.
Due to the seniority of the position we are seeking candidates who have held Executive director in multinationals OR VP level roles in smaller companies. FDA experience is essential for this role!
Please note: Only candidates meeting the requirements set out in the role profile above will be considered in the application process.
Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.
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