Medical Device - Regulatory Affairs Manager - (Hybrid in Ohio, US)

Our client, a growing medical device company based in Ohio, 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 ensuring compliance with regulatory guidelines and standards while facilitating the timely approval and commercialization of sterile devices.

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.
• Act as a subject matter expert and provide training and mentorship to team members on regulatory affairs principles and practices.

Requirements:

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
• A minimum of 5 years of experience in regulatory affairs within the medical device industry, with specific expertise in sterile medical devices.
• Proven track record of successful regulatory approvals for sterile medical devices, including 510(k) submissions and EUMDR
• Strong knowledge of FDA regulations (including MDR), international regulations (e.g., EU MDR, Health Canada), and industry standards (ISO 13485, ISO 14971)
• 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.

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

...@barringtonjames.com