Sr. Regulatory Specialist

Arevna; Windsor; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading company in the medical device industry is seeking a Regulatory Specialist who will lead the preparation of FDA submissions and ensure compliance with international regulations. This role requires at least 3 years of experience in regulatory affairs and involves liaising with cross-functional teams and managing audits, providing an excellent opportunity for professional growth in a pivotal sector.

Qualifications

• Minimum 3 years of experience in regulatory affairs within the medical device industry.
• Demonstrated experience preparing and submitting FDA 510(k) applications.
• Strong understanding of MDSAP requirements.

Responsibilities

• Lead the preparation and submission of FDA 510(k) applications for Class II medical devices.
• Ensure compliance with MDSAP audit requirements.
• Act as a contact during audits and inspections.

Skills

Organizational skills

Project management skills

Communication skills

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering or a related discipline

Job description

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Head of Commercial @ Arevna | Delivering high performing teams in MedTech.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Writing/Editing and Quality Assurance

• Industries

  Medical Equipment Manufacturing

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