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:
1. Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
2. Mini...