Regulatory Affairs Lead for Global Medical Device Projects
7 days ago
We are seeking a highly skilled Regulatory Affairs Lead to join our team at Allergan Aesthetics. As a key member of our regulatory affairs department, you will be responsible for developing and executing regulatory strategic plans to ensure compliance with US and EU regulations.
SalaryThe estimated salary range for this position is $120,000 - $180,000 per year, depending on experience and qualifications.
Job DescriptionThe Regulatory Affairs Lead will represent the company in regulatory matters, developing and communicating regulatory strategic plans to global regulatory leads and project teams. This role requires a deep understanding of US and EU medical device regulations, as well as excellent communication and negotiation skills.
Key responsibilities include:
- Developing and executing regulatory filing strategies for US and EU submissions
- Providing regulatory guidance to global product owners and project teams
- Communicating with regulatory agencies, including the FDA and Notified Bodies
- Maintaining relationships with cross-functional partners, including operations, commercial, and medical affairs
To be successful in this role, you will need:
- A degree in a scientific field, plus 8 years of experience in regulatory affairs or related field
- Proven experience in US medical devices regulatory affairs, including submissions to the FDA
- Advanced knowledge of US and EU medical device regulations
- Excellent analytical and problem-solving skills, with ability to follow through on tasks
- Excellent communication and interpersonal skills, with ability to lead and negotiate
We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and a 401(k) plan. Additionally, eligible employees may participate in our short-term and long-term incentive programs.
Equal Employment Opportunity EmployerAllergan Aesthetics is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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