Nova Biomedical: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

About the company

At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.

Explore what’s next with us at novabiomedical.com or aicompanies.com

About the role

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!

What you’ll do

• 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

What we are looking for in you

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

Physical Requirements for this role include:

• The ability to travel by car or airplane as needed
• The ability to work while standing or sitting for prolonged periods
• The ability to work on a laptop or desktop computer for prolonged periods
• The ability to lift at least 35 lbs
• The full list of physical requirements for this role is available upon request.

Why work for Nova Biomedical

• 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

Work Location: Hybrid work schedule, onsite in our Waltham, MA office

Targeted Salary Range: $210,000 - $270,000/year.

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.

EEO Statement:

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Privacy policy

https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW