Regulatory Affairs Manager

Regulatory Affairs Manager - (Electromechanical Devices) - US Based Candidates Only

Our client, an established and still growing medical device company, is seeking an experienced and dedicated Regulatory Affairs Manager to join their dynamic team.

As the Regulatory Affairs Manager, you will play a crucial role in bringing exciting products to market and leading regulatory submissions.

Responsibilities:

• Develop and implement regulatory strategies to support product development, registration, and post-market compliance for sterile medical devices.
• Collaborate cross-functionally with R&D, Clinical Affairs, Quality Assurance, and Manufacturing teams to ensure compliance with regulatory requirements throughout the product lifecycle.
• Stay updated with new regulations and changes in US and global Regulatory requirements, such as the EU MDR
• Conduct regulatory assessments and gap analyses to identify potential compliance issues and develop strategies for resolution.
• Keep abreast of global regulatory requirements, guidelines, and industry best practices related to sterile medical devices, and provide guidance to the organization accordingly.
• Interact and build relationships with regulatory authorities and notified bodies to facilitate timely and successful regulatory approvals.
• Support internal and external audits and inspections related to regulatory affairs and ensure timely closure of any findings or observations.
• Lead a new 510k submission.

Requirements:

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
• A minimum of 4 years of experience in regulatory affairs within the medical device industry, with specific expertise in electromechanical medical devices.
• Proven track record of successful regulatory approvals for electromechanical medical devices, including 510(k) submissions and CE Marking
• Strong knowledge of FDA regulations (including MDR), international regulations (e.g., EU MDR, Health Canada), and industry standards (ISO 13485, ISO 14971, IEC 60601)
• Experience interacting with regulatory authorities and notified bodies, with a solid understanding of their expectations and requirements.
• Familiarity with clinical study design and regulatory requirements for investigational studies.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to cross-functional teams.
• Detail-oriented mindset with strong analytical and problem-solving abilities.
• Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced and dynamic environment.
• Professional certifications such as RAC are highly desirable.

Please note that our client cannot support sponsorship at this time.

If you would like to learn more about this Regulatory Affairs Manager opportunity, apply today or contact me directly on the following:

wjlynch@barringtonjames.com