Director, Regulatory & Clinical Affairs

Nova Biomedical Corporation • Waltham, MA

2d • Hybrid

About The Position

The Director of Regulatory & Clinical Affairs will oversee and lead the Regulatory Affairs Department to ensure global regulatory requirements are met for Nova products, including compliance with US FDA CFR Title 21 Part 820 (Quality System Regulation), ISO 13485:2016, Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch. 3), Canadian Medical Device Regulations (SOR/98-282), Brazil GMP (RDC ANVISA 16/2013), and Japan (MHLW Ministerial Ordinance No. 169). This role serves as Deputy Person Responsible for Regulatory Compliance (PRRC) and is responsible for the leadership, development, and management of an effective and compliant Regulatory Affairs team, working closely with cross-functional partners to ensure processes meet regulatory expectations and support operational excellence. The Director will lead global new product registrations and clearances, oversee mandatory re-registrations, and ensure implementation of new or revised regulatory requirements mandated by local, federal, and international standards. If you’re passionate about regulatory affairs and want to be part of a team that is shaping the future of life sciences, we’d love to hear from you, apply today!

Requirements

• Previous leadership experience with 510(k), Health Canada, International Device Submissions, Licensing and Registration experience, ISO/FDA QSR, IVDD, ISO:13485 knowledge
• Strong working knowledge of MDSAP, ISO13485, Australian Therapeutic Goods (TG(MD)R Sch. 3), Japan (MHLW Ministerial Ordinance No. 169), Canadian Medical Device Regulations (SOR/98-282), Brazil GMP (RDC ANVISA 16/2013) and FDA Regulations (21CFR Part820)
• Excellent analytical and written and oral communication skills and the ability to work well under pressure with cross functional teams
• Results oriented, effective team player
• Excellent technical writing skills
• Strong project management, organizational, mentoring, and leadership skills
• Strong computer literate in Word and PowerPoint
• Bachelor's degree or higher in a technical discipline, preferably life sciences, chemistry or medical technology field, Masters or Ph.D. degree preferred but not required
• 10-15 years Medical Device/IVD Experience in an FDA regulated reagents, medical device or IVD manufacturing company.
• Less experienced candidates (5-10 years) will be considered that have strong IVD POC Device experience

Nice To Haves

• Previous experience with IVD Point-of-Care (POC) or clinical laboratory products is preferred

Responsibilities

• Determining effective regulatory pathways for a variety of product types
• Participate in cross-functional teams to implement regulatory strategies for the timely support of project team goals.
• Ensures product development projects and changes to existing products are conducted in compliance with the appropriate regulations
• Leads RA team in the preparation of IDE submissions, 510(k), IVDR/IVDD CE Mark Technical Files, and other related regulatory filings for the U.S. and International
• Interface with FDA, Notified Bodies, and other international regulatory agencies regarding regulatory submission strategy and approval reviews
• Collaborate with R&D and MASA to determine and execute pre-clinical test plans to support regulatory submissions,
• Acts as Deputy Person Responsible for Regulatory Compliance (PRRC) for the EU under IVDR
• Maintain current knowledge of competitive technologies in addition to medical and technical developments related to the company’s products
• Acts as the Deputy Management Representative for the company QMS

Benefits

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

What This Job Offers

• Job Type: Full-time
• Career Level: Director