elemed
Senior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | Quality
Role:
Director Regulatory Affairs
The company
This is an exciting position to join a world‑leading company at the forefront of making healthcare more accessible through its active devices. With over 50,000 employees worldwide, the Regulatory Director will lead one of the most important, long‑standing active device product ranges for the company and its RA team across EMEA.
This is a US‑market strategy and team‑leadership role focused on one active device product range. The RA team size is approximately 10 people covering various responsibilities in regulatory affairs including:
Premarket support to product development
Full product lifecycle management responsibility
New product introductions
Regional and some global RA strategy across your portfolio
Post‑market regulatory activities
This role offers a high level of exposure and growth potential within the company, reporting directly to a Director of RA and collaborating closely with other Directors and internal stakeholders.
As the Director RA, you will:
Work with the Director to formulate the regulatory strategy for the product range, controlling budgets for the US market
Help push new harmonisation regulatory strategies with business goals, ensuring they are implemented and executed
Lead a department of approximately 10 regulatory staff in the US
Develop and manage emerging leaders to improve overall performance
Provide guidance on regulatory changes with the FDA and opportunities to legal teams, senior director, and executive management
Develop regulatory strategies for maintenance and new product introduction in the product range on US markets
Manage the lifecycle of the product range and FDA submissions
Lead negotiations with the FDA
Collaborate with quality, clinical, R&D, marketing, and business unit leaders
Foster strong collaborative relationships with these partners to achieve business objectives
We are looking for successful regulatory professionals with a proven track record of team leadership and experience working with active devices.
If you are excited by the prospect of working in a multifaceted environment and building strong relationships with both internal and external partners, this could be a great career step for you!
To be a Director RA, you will ideally bring:
Minimum of 3 years leading a Regulatory team in medical device companies
Premarket regulatory experience with active (electrical) medical devices
Proven track‑record experience interacting with the US FDA
Interested in exploring this further? Please send your resume to Frankie@elemed.eu to arrange a confidential career discussion.
⚖️ 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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Director Regulatory Affairs
The company
This is an exciting position to join a world‑leading company at the forefront of making healthcare more accessible through its active devices. With over 50,000 employees worldwide, the Regulatory Director will lead one of the most important, long‑standing active device product ranges for the company and its RA team across EMEA.
This is a US‑market strategy and team‑leadership role focused on one active device product range. The RA team size is approximately 10 people covering various responsibilities in regulatory affairs including:
Premarket support to product development
Full product lifecycle management responsibility
New product introductions
Regional and some global RA strategy across your portfolio
Post‑market regulatory activities
This role offers a high level of exposure and growth potential within the company, reporting directly to a Director of RA and collaborating closely with other Directors and internal stakeholders.
As the Director RA, you will:
Work with the Director to formulate the regulatory strategy for the product range, controlling budgets for the US market
Help push new harmonisation regulatory strategies with business goals, ensuring they are implemented and executed
Lead a department of approximately 10 regulatory staff in the US
Develop and manage emerging leaders to improve overall performance
Provide guidance on regulatory changes with the FDA and opportunities to legal teams, senior director, and executive management
Develop regulatory strategies for maintenance and new product introduction in the product range on US markets
Manage the lifecycle of the product range and FDA submissions
Lead negotiations with the FDA
Collaborate with quality, clinical, R&D, marketing, and business unit leaders
Foster strong collaborative relationships with these partners to achieve business objectives
We are looking for successful regulatory professionals with a proven track record of team leadership and experience working with active devices.
If you are excited by the prospect of working in a multifaceted environment and building strong relationships with both internal and external partners, this could be a great career step for you!
To be a Director RA, you will ideally bring:
Minimum of 3 years leading a Regulatory team in medical device companies
Premarket regulatory experience with active (electrical) medical devices
Proven track‑record experience interacting with the US FDA
Interested in exploring this further? Please send your resume to Frankie@elemed.eu to arrange a confidential career discussion.
⚖️ 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.
#J-18808-Ljbffr