HYBRID Regulatory Affairs Senior - Medical - Westwood, MA

The Regulatory Affairs Specialist will oversee the implementation of quality systems and strategies to ensure the company's products meet regulatory standards, driving continuous improvement across production lines. They will collaborate closely with R&D, commercial, and quality teams to maintain compliance and ensure product quality across multiple sites at the Westwood facility.

Client Details

My client is a global provider of scientific and analytical solutions specializing in biopharma, clinical, and food & beverage industries. They focus on providing reliable and innovative instruments, services, and software to help organizations improve quality, ensure reliable outcomes, and boost productivity. Their portfolio includes advanced technologies for liquid handling, cell line development, and osmolality testing, backed by strong customer service and support. With a mission to optimize processes and deliver innovation, they are committed to improving health outcomes through their advanced solutions. The company operates worldwide, ensuring high-quality service in various markets, including biopharma, healthcare, and food. They are based out of Westwood, MA.

Description

The Regulatory Affairs Specialist, Medical Manufacturing will:

• Lead IVDR transition efforts, ensuring compliance with new regulations.
• Develop and implement regulatory strategies for product approvals.
• Oversee product registrations and maintain global regulatory compliance.
• Prepare and submit accurate regulatory documentation for Class I/II medical devices.
• Act as the primary liaison with regulatory agencies, including US FDA and international authorities.
• Collaborate with R&D, commercial, and quality teams to address regulatory challenges.
• Ensure post-market surveillance compliance and manage product lifecycle.
• Support the preparation and execution of quality system audits.
• Drive continuous improvement and quality culture across teams.
• Manage and oversee consultants, contractors, and interns supporting regulatory affairs.
• Facilitate communication between regulatory authorities and internal teams.
• Provide regulatory guidance and leadership for new product launches.
• HYBRID - two days per week at home

Profile

• 10+ years of experience in regulatory affairs, including medical devices and IVD regulatory submissions (Class I, II, IVDR).
• Proficiency in EU IVD Regulations/Directives and global quality system standards.
• Experience with IVDR and transitioning from IVDD.
• Expertise in regulatory submissions, technical files, and product lifecycle compliance.
• Strong organizational, communication, and collaboration skills.
• Experience with MDSAP, global registration, and licensing (US, EU, Canada, Japan, Brazil).
• Strong experience in managing regulatory challenges and product registrations globally.
• Ability to lead cross-functional teams and drive compliance in all phases of product development.
• Growth-oriented with the ability to expand team functions.
• Knowledge of post-market surveillance processes.
• Proficient in using regulatory and compliance software and tools.
• Experience working with international regulatory agencies, including US FDA and Notified Bodies.

Apply today for review of your resume within 48 business hours!

Job Offer

• Exceptional 401(k) match with no cap beyond government limits
• Comprehensive health insurance, including supplemental insurance to help cover deductibles
• Life insurance, short- and long-term disability insurance provided
• Tuition reimbursement for professional development
• Dynamic and diverse company with a focus on innovation across healthcare, biotech, and food & beverage industries
• Opportunity to contribute to cutting-edge technologies and solutions in a global setting
• Work in a collaborative, mission-driven environment where customer satisfaction and quality are at the forefront
• HYBRID WORK SCHEDULE - work from home twice per week

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.