Regulatory Affairs Manager

The overall goal of the Regulatory Affairs Manager is to ensure regulatory clearance for all FX products in all markets and compliance with all applicable regulations. It is expected that the Regulatory Affairs Manager will have a full understanding of the FX Shoulder product portfolio.

• Oversight of the company’s regulatory functions.
• Support and/or lead FDA and MDR new and ongoing submissions as required.
• Clear products in new markets globally as required by the business.
• Manage Regulatory Affairs department, personnel, and budget.
• Determine regulatory objectives and develop processes to achieve organizational goals.
• Coordinate regulatory submissions in all markets and ensure project deadlines are met.
• Track registrations, renewals, and all annual filings and fees.
• Work with R&D to create and maintain DHF documents and Technical Documentation.
• Provide regulatory strategies for new product development projects.
• Submit notifications of significant changes to competent authorities, notified bodies, and authorized reps.
• Answer questions from competent authorities, notified bodies, authorized reps, and international distributors and provide documentation as needed.
• Ensure compliance with regulatory and registration requirements in all jurisdictions.
• Keep up to date with changes in regulatory legislation and guidance.
• Conduct annual audits and review contracts of authorized reps and international distributors.
• Provide regulatory support during third-party audits of the company quality system and product documentation.
• Work with Clinical Affairs to submit updated Post-Market Surveillance plans and reports, PSURs,
• Maintain familiarity with company product lines.
• Advise the company regarding policies, practices, and systems to ensure compliance with regulations and requirements of competent authorities.
• Liaise and negotiate with regulatory authorities.

• 5+ years’ experience in progressive positions with responsibilities for regulatory affairs in the international medical device market.
• Demonstrated success in the medical device industry with organizational development, leadership, and team building responsibilities.
• Demonstrated success in medical device regulatory submissions in the US, the EU under MDR, and
• Highly oriented towards customer service and quality improvement.
• Ability to work in a multi-cultural organization.
• Ability to contribute in any way necessary to get the work done.
• Ability to work in a fast-paced, driven organization.
• Strong written and verbal communication skills.
• Ability to travel up to 10%.
• Proficiency or fluency in Spanish and/or French is a plus.