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.