▷ [Apply Now] Sr. Regulatory Specialist...

Job Description 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.