Senior Regulatory Consultant

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

• 7+ years of medical device regulatory experience, including strategic leadership of product development programs.
• Advanced degree (Master's, PhD, or equivalent) in science, engineering, business, or a related field preferred.
• Prior FDA, regulatory authority, or medical device industry experience required.
• Expertise in one or more areas, including regulatory affairs, clinical strategy, non-clinical testing, engineering, combination products, or IVDs.
• Strong knowledge of global medical device regulations, standards, and quality systems (FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, PMDA, etc.).
• Demonstrated ability to develop regulatory strategies, assess regulatory impact, and support interactions with global regulatory agencies.
• Strong analytical, problem-solving, communication, writing, and presentation skills.
• Ability to lead cross-functional teams, manage multiple priorities, and deliver high-quality results within timelines and budgets.
• Commitment to continuous learning and professional development in emerging regulatory and industry topics.

• The physical demands described here must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands to finger, handle, or feel, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and the ability to adjust focus.
• Extensive use of a computer keyboard.
• Travel approximately 5 to 10% of the time.

The compensation grade range for this position is:

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Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.