Job Description

💼Role: Director Regulatory Affairs

📍Location: San Diego, California, USA

📤Contact: Frankie@elemed.eu

🟧The company

This is an exciting position to join a world leading company at the forefront making healthcare more accessible through its active devices. With over 50,000 employees worldwide, the Regulatory Director will be leading one of the most important, long-standing active device product ranges for this company and its RA team across EMEA.

This is a US-market strategy and team leadership role with a focus on one active device product range. The RA team size is approx. 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 is a position with a high level of exposure and growth potential within the company, and reports directly to a Director of RA and strong collaboration with other Directors and other internal stakeholders.

🟦As the Director RA, you will:

• Work with the Director and formulate the regulatory strategy for the product range, controlling budgets for the US-market
• Helping to push through new harmonisation regulatory strategies with business goals and ensuring they are implemented and executed
• Lead a department of approx. 10 regulatory staff in the US
• Develop and manage upcoming 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 the maintenance and new product introduction in the product range on the US-markets
• Manage the lifecycle of the product range and submissions with the FDA
• Take lead on negotiations with the FDA
• Your internal partners will be quality, clinical, R&D, marketing and business unit leaders
• Your role will be to foster strong collaborative relationships with these partners in order to achieve business objectives
• Manage escalations accordingly

We are looking for successful regulatory professionals with a proven track record of team leadership and worked with active devices.

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 a Director RA, you will bring ideally:

• Minimum of 3 years leading a Regulatory team in medical devices companies
• Premarket regulatory experience with active (electrical) medical devices
• Fluent English
• 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.

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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