Sr. Regulatory Specialist in Windsor

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.

Extra information

Status

Open

Education Level

Secondary School

Location

Windsor

Type of Contract

Part-time jobs

Published at

06-07-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English