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Regulatory Affairs Specialist II

Billerica, MA 01821

Posted: 09/14/2023 Job Number: 32983

Job Description

Position Summary: The Regulatory Affairs Specialist II reports to the Manager of Regulatory Affairs and is responsible for creating, preparing, and coordinating regulatory submissions and approvals in both domestic and international markets. The role involves collaborating with regulatory, R&D, and Quality teams to develop and implement regulatory strategies. Additionally, the specialist contributes to the design and development of new medical devices to enhance patient and physician care.

  • Maintain and update EU Technical Files to ensure compliance with current regulatory and company standards. Also, update clinical evaluation documentation to support EU and international regulations.
  • Prepare regulatory filings for new products and significant post-market changes. Handle complex regulatory issues as necessary.
  • Provide regulatory support for new product development and align on-market product development documentation with the latest regulatory requirements. Ensure ongoing regulatory compliance throughout the product development process.
  • Prepare and submit regulatory submissions for US device 510(k), EU, Canada, Australia, and other international markets to facilitate business growth.
  • Oversee post-market surveillance and revise risk management documentation as applicable.
  • Support regulatory documentation for commercialized products, including International registrations, Regulatory Assessments, and 510(k) applications.
  • Focus on improving technical files and risk management documentation.
  • Review product and manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.
  • Manage product listing, licensing, and all appropriate registrations on a global scale.
  • Ensure compliance with the design control process and Quality Management System.
  • Provide technical guidance and regulatory training/mentoring to other members of the Regulatory Affairs team.

Qualifications and Experience:

  • Bachelor's degree in engineering or science is required. An MS in Regulatory Affairs is preferred.
  • Minimum of 6+ years' experience in a regulated industry or 3+ years with an advanced degree.
  • Knowledge of domestic (FDA) and foreign regulatory requirements for medical device manufacture and distribution, particularly in design control and technical file compilation.
  • Strong ability to meet deadlines, prioritize work, take initiative, follow up on outstanding issues, complete assigned tasks, handle multiple tasks, and work independently.
  • Effective communication skills (verbal and written) for internal and external interactions, including third-party regulators.
  • Experience with FDA and EU applications for clearance/approval is essential.

Meet Your Recruiter

Fran Hardy

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