Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist - Permanent - Boston MA

Can you transform regulatory challenges into opportunities that accelerate innovation in medical devices?

Proclinical is working alongside a medical device company based in the suburbs of Boston who are looking to hire a Senior Regulatory Affairs Specialist.



This role has an on-site requirement of 3-4 days per week, so please do not apply unless this is an option for you.

Skills & Requirements:

• The ideal candidate has a solid technical background and several years of experience in regulatory affairs for medical devices.
• They bring proven expertise in preparing global submissions, managing post-market requirements, and navigating international regulatory frameworks.
• They are comfortable working with complex technologies, communicating effectively across technical and commercial teams, and producing clear, well-structured documentation.
• Strong organizational and project management skills are essential, as is the ability to handle multiple priorities.
• Applicants must have legal authorization to work in the United States.

The Sr Regulatory Affairs Specialist's responsibilities will be:

• In this role, you'll lead global regulatory activities for an innovative medical device portfolio, guiding strategy, submissions, and compliance across multiple markets.
• You'll partner closely with cross-functional teams to support product development, ensure documentation and filings are delivered to a high standard, and maintain alignment with evolving international regulations.
• You'll also help manage interactions with regulatory authorities, oversee post-market requirements, and contribute to efficient processes and clear communication across the organization.
• This position is ideal for someone who enjoys collaborating, solving complex regulatory challenges, and driving projects forward independently.

Compensation:

• $130,000 to $140,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact Christian Andersen at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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