Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to support the preparation and submission of regulatory documents to health authorities, ensuring compliance with global regulations for medical devices.

Requirements

• Prepare and submit regulatory filings (e.g., 510(k)s, Technical Files, Design Dossiers, PMAs) to global health authorities in accordance with applicable regulations and company procedures.
• Review and assess proposed product changes for regulatory impact and ensure timely updates to existing regulatory submissions.
• Support the development and maintenance of regulatory strategies for new product development and existing product lines.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Marketing, Clinical) to ensure regulatory requirements are integrated throughout the product lifecycle.
• Participate in internal and external audits and inspections, providing regulatory expertise and documentation as needed.
• Monitor and interpret new and evolving global regulations, standards, and guidance documents relevant to medical devices.
• Maintain accurate and organized regulatory documentation and databases.
• Assist in responding to regulatory agency inquiries and requests for information.
• Provide regulatory support for post-market surveillance activities, including adverse event reporting and recall support.

Benefits

• Health and Well-being Benefits
• Other Well-being Resources
• Retirement and Financial Well-being
• Life Balance Programs
• Other Life Balance Programs
• Leave Programs