Role: Executive Director / VP Divisional Regulatory Affairs
Location: Vaud, Switzerland
Contact: Frankie@elemed.eu
????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
* Acts as the voice of the business in discussions with global regulatory agencies; empowers 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)
* Fluent English
* 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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???? Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.
We won Best International Recruitment Agency at the Recruiter Awards 2021.
At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.
️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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