Regulatory Affairs Manager- Medical Device- Westwood, Ma

The RA Manager leads global regulatory strategies across multiple sites and product lines, ensuring compliance with international regulations and driving product approvals. This role offers leadership opportunities, cross-department collaboration, and exposure to complex global markets, including navigating evolving regulations like the IVDD to IVDR transition.

Client Details

The company is a leading provider of innovative analytical instruments and solutions, specializing in high-quality products for laboratory and industrial applications. With a focus on precision and reliability, it serves a wide range of sectors, including healthcare, biotechnology, and life sciences, ensuring efficient and accurate results across its global operations.

Description

• Develop and implement regulatory strategies to ensure timely approvals of new and existing products.
• Manage and maintain product registrations, licenses, and global regulatory compliance.
• Serve as the primary contact with regulatory agencies (US FDA, Authorized Representatives, Notified Bodies, and other international entities).
• Oversee the preparation of regulatory submissions and updates, ensuring accuracy and compliance.
• Facilitate communication between regulatory authorities and company representatives.
• Ensure regulatory compliance throughout the product lifecycle, including post-market surveillance.
• Manage the transition from IVDD to IVDR compliance for impacted products.
• Collaborate with the Quality Assurance team to support quality system processes and audits.
• Support the expansion of the Regulatory Affairs team, including hiring, training, and performance evaluations.
• Manage or oversee consultants, contractors, and interns to support Regulatory Affairs projects.
• Promote a culture of quality, continuous improvement, and compliance within the organization.

Profile

• At least 10 years of regulatory compliance experience, with a focus on Class I and Class II (IVDD and IVDR Class A/B/C) medical devices.
• In-depth knowledge of MDSAP, EU IVD Directive/Regulation, and quality system standards.
• Proven expertise in creating Technical Files and documentation compliant with IVDR, including the transition from IVDD to IVDR.
• Extensive experience in global product registration and licensing across regions such as the US, Canada, Brazil, Japan, EU, Australia, and APAC.
• Excellent organizational, written, and verbal communication skills.

Job Offer

• Leadership Opportunities: Lead global regulatory strategies and oversee regulatory activities across multiple sites and product lines, with the potential to grow and manage the Regulatory Affairs team.

• Global Impact: Work on regulatory compliance and product registrations across key international markets like the US, EU, Canada, Japan, and more, making a significant impact on medical device approvals.

• Professional Growth: Gain valuable experience in the evolving regulatory landscape, including the IVDD to IVDR transition, and enhance your expertise in high-demand regulatory areas.

• Collaborative Environment: Work closely with cross-functional teams such as R&D, product management, and quality assurance, fostering a dynamic, team-oriented workplace.

• Continuous Improvement Culture: Contribute to a company-wide focus on quality, compliance, and continuous improvement, directly influencing business success.

• Hybrid Work Setup: Enjoy a flexible work arrangement with a hybrid model, balancing on-site and remote work to suit your lifestyle.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.