Sr. Regulatory Affairs Specialist - Diagnostics - Westwood, MA

Participate in developing global regulatory strategies, along with coordinating associated registrations or submissions in regards to market clearance/approval. Contribute to providing direction to project teams for product development/design control related activities, while ensuring regulatory compliance throughout the product life cycle.

Client Details

One of my best clients, which we have made numerous placements with is a leading provider of precision laboratory instruments and analytical solutions designed to ensure accuracy and compliance in critical industries such as pharmaceuticals and biotechnology. They specialize in cutting-edge measurement technologies, helping organizations improve quality control, streamline work flows, and meet regulatory standards. With a strong reputation for innovation and reliability, they offer a dynamic work environment where employees contribute to advancements in scientific and industrial research.

Description

• Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams.
• Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
• Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.
• Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
• Performs targeted gap analyses, highlighting pertinent regulatory considerations based on knowledge of regulations, guidance documents, and predicate product approval

Profile

• BS in Regulatory Affairs or Scientific Discipline, or equivalent experience.
• 8+ years in Regulatory Affairs with Product Development experience.
• Organized, detail oriented, and excellent written and oral communication skills.
• Excellent knowledge and experience with global medical device regulatory requirements, design control and product registration.
• Experience in regulatory compliance, product development & process management

Job Offer

• Competitive compensation and benefits
• Opportunity for career advancement
• Directly impact products that contribute to saving lives
• Join a company known for its cutting edge technology and advanced solutions
• Work in a supportive team setting where expertise in regulatory affairs is highly valued and encouraged for career development.

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.