Melio Life Science is partnered with a leading mid-sized medical device company specialising in the manufacturing of catheters. Recently acquiring an office in Europe, they are looking for a Regulatory Affairs Manager to join their team.
Position Overview:
They are seeking a highly skilled and experienced Regulatory Affairs Manager to join their team in Minnesota. Reporting to the Vice President Quality and Regulatory, the ideal candidate will have a minimum of 6 years of regulatory affairs experience within the medical device industry, with a strong background in regulatory compliance, ISO 13485, and experience in either 510(k) or PMA submissions. The Regulatory Affairs Manager will play a pivotal role in ensuring compliance with regulatory requirements and driving the successful approval and commercialization of our innovative catheter products.
Key Responsibilities:
· Lead regulatory strategy development and execution for new product development, including preparation and submission of regulatory filings such as 510(k) or PMA submissions.
· Collaborate cross-functionally with R&D, Quality Assurance, Manufacturing, and Clinical teams to ensure regulatory requirements are integrated into product development processes and timelines.
· Provide regulatory guidance and support throughout the product lifecycle, including regulatory compliance assessments, regulatory submissions, and post-market surveillance activities.
· Stay abreast of changes in regulations, standards, and guidance documents relevant to medical devices, and communicate updates to internal stakeholders.
· Manage a team of regulatory affairs professionals, providing mentorship, guidance, and fostering a culture of excellence and continuous improvement.
· Serve as the primary point of contact for regulatory agencies and notified bodies, including representing the company during regulatory audits and inspections.
· Lead regulatory assessments for new markets and support international registrations and submissions as needed.
· Drive regulatory intelligence activities to anticipate and mitigate regulatory risks and ensure proactive compliance.
Requirements
· Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
· Minimum of 6 years of progressive experience in regulatory affairs within the medical device industry, with specific experience in catheter products preferred.
· Strong understanding of regulatory requirements and standards, including ISO 13485, FDA regulations (21 CFR Part 820), and international regulations (e.g., EU Medical Device Regulation).
· Proven experience in preparing and submitting regulatory filings, including 510(k) or PMA submissions.
· Excellent interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams and communicate regulatory requirements and strategies.
· Demonstrated leadership experience, including the ability to effectively manage a team and drive results in a fast-paced environment.
· Strong analytical skills and attention to detail, with the ability to assess complex regulatory issues and develop practical solutions.
· Ability to adapt to changing priorities and manage multiple projects simultaneously while meeting deadlines.