Director of Regulatory Affairs
4 weeks ago
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 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 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 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. 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. ___________________________________________________________________ ⚖️ 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
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Director, Regulatory Affairs
2 weeks ago
San Diego, United States BD Nogales Norte Full timeJoin to apply for the Director, Regulatory Affairs role at BD Nogales Norte 2 days ago—Be among the first 25 applicants. BD is one of the largest global medical technology companies in the world. The company’s purpose is Advancing the world of health™, and it is built on the imagination and passion of teams across design, engineering, manufacturing,...
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Director, Regulatory Affairs
4 weeks ago
San Diego, United States Becton Dickinson Full timeDirector of Regulatory Affairs BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us from design and engineering to the manufacturing and marketing of our billions of MedTech products per year to look at the impossible...
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Director, Regulatory Affairs
4 weeks ago
San Diego, United States California Staffing Full timeDirector Of Regulatory AffairsBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and...
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Director, Regulatory Affairs
2 weeks ago
San Diego, CA, United States Becton Dickinson & Company Full timeJob Description Summary Job Description We are the makers of possible! BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...
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Director, Regulatory Affairs
3 days ago
San Diego, CA, United States Becton Dickinson & Company Full timeJob Description Summary Job Description We are the makers of possible! BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...
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Director, Regulatory Affairs
5 days ago
San Diego, CA, United States Becton Dickinson & Company Full timeJob Description Summary Job Description We are the makers of possible! BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...
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Associate Director Regulatory Affairs
3 weeks ago
San Diego, United States San Diego Staffing Full timeAssociate Director Of Regulatory AffairsWe are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech...
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San Diego, United States Rakuten Medical Full timeDirector/Senior Director of Global Regulatory Affairs Director/Senior Director of Global Regulatory Affairs – Rakuten Medical Company Profile Rakuten Medical, Inc. is a global biotechnology company developing precision, cell‑targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads...
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Associate Director Regulatory Affairs
2 days ago
San Diego, United States BD Nogales Norte Full timeJoin to apply for the Associate Director Regulatory Affairs role at BD Nogales NorteBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products...
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Regulatory Affairs Director
5 days ago
San Diego, United States Truvian Full timeRegulatory Affairs DirectorTruvian is seeking an experienced and hands-on Regulatory Affairs Director to lead and execute all aspects of the company's global regulatory strategy. This leadership role will be responsible for supporting regulatory submissions and product registrations across domestic and international markets, ensuring compliance with...
