Position Overview

We are seeking an experienced Manager of Regulatory Affairs to lead and oversee regulatory strategies and submissions for our medical device and IVD products. This role requires a hands-on leader who thrives in a fast-paced environment, ensuring compliance with global regulatory requirements while supporting product innovation and market expansion.

Key Responsibilities

• Regulatory Strategy: Develop and implement regulatory strategies for new and existing products, ensuring alignment with business goals and global regulatory requirements.
• Submissions: Prepare, review, and submit regulatory documents, including 510(k)s, PMAs, Technical Files, Design Dossiers, and other regulatory submissions for FDA, EU MDR/IVDR, and other international markets.
• Compliance: Ensure products meet applicable regulatory standards, including ISO 13485, FDA QSR, EU MDR/IVDR, and other relevant regulations.
• Team Leadership: Manage and mentor a team of regulatory professionals, fostering professional growth and high performance.
• Cross-Functional Collaboration: Partner with R&D, Quality, Marketing, and other departments to support product development, labeling, and market access strategies.
• Risk Management: Assess and mitigate regulatory risks, keeping the leadership team informed of potential challenges and opportunities.
• Regulatory Intelligence: Stay up-to-date on changes in global regulatory requirements and communicate implications to relevant stakeholders.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field (Master’s or advanced degree preferred).
• 5+ years of experience in regulatory affairs within the medical device or IVD industry.
• Proven track record of successful regulatory submissions (e.g., 510(k), PMA, CE Mark).
• Strong knowledge of global regulations, including FDA, EU MDR/IVDR, Health Canada, and other international requirements.
• Experience with Quality Management Systems (ISO 13485, FDA QSR).
• Excellent communication, leadership, and project management skills.
• RAC certification is a plus.