Sr. Regulatory Specialist

About the Role: Arevna is partnering with an innovative and growth-focused medical device manufacturer to recruit a Regulatory Specialist with hands-on experience in 510(k) submissions and MDSAP compliance. This is a fantastic opportunity to join a company committed to delivering high-quality, compliant products to global markets. Key Responsibilities: Lead or support the preparation and submission of FDA 510(k) applications for Class II medical devices. Ensure the company’s Quality Management System and product documentation meet MDSAP audit requirements across applicable markets (e.g., US, Canada, Australia, Brazil, Japan). Liaise with cross-functional teams to compile technical documentation and support global regulatory strategies. Interpret and implement evolving regulatory requirements in target markets. Act as a point of contact during audits and inspections, including FDA, MDSAP, and notified body reviews. Maintain comprehensive and organized regulatory files for both pre-market and post-market activities. Support post-market regulatory compliance, including vigilance reporting and regulatory updates. Candidate Profile: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline. Minimum 3 years of experience in regulatory affairs within the medical device industry. Demonstrated experience preparing and submitting FDA 510(k) applications. Solid understanding of and practical experience with MDSAP requirements. Knowledge of international medical device regulations (e.g., FDA, EU MDR, ISO 13485, Health Canada, TGA, ANVISA). Strong organizational and project management skills. Excellent communication and interpersonal skills. RAC certification or similar credential is a plus.

Location: Windsor, GB

Posted Date: 5/25/2025