Senior Regulatory Consultant

NAMSA; Diest; Vor Ort; EUR 91.000 - 177.000; Vollzeit

Zusammenfassung

NAMSA is seeking a senior regulatory leader to shape and drive global regulatory strategies for medical devices, in vitro diagnostics, and combination products across all development stages.

You will serve as the primary regulatory consultant for clients, preparing submissions and guiding interactions with FDA, Health Canada, and other regulators while leading cross-functional teams and mentoring colleagues.

Qualifikationen

• 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 regulatory affairs, clinical strategy, non-clinical testing, engineering, or IVDs.
• Strong knowledge of global medical device regulations, standards, quality systems (FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, PMDA, etc.).

Aufgaben

• Lead the development and execution of global regulatory strategies for medical devices, in vitro diagnostics, combination products, and related technologies across all stages of product development.
• Serve as the primary regulatory consultant for clients, providing scientific, technical, and strategic guidance to support regulatory approvals, market access, and commercialization objectives.
• Prepare, review, and support regulatory submissions and interactions with health authorities and conformity assessment bodies, including FDA, Health Canada, and other global regulators.
• Develop and review regulatory assessments, technical documentation, clinical and preclinical strategies, testing plans, and supporting evidence packages.
• Lead cross-functional project teams and collaborate with clinical, quality, biostatistics, reimbursement, and laboratory experts to deliver integrated client solutions.

Kenntnisse

Regulatory strategy

Regulatory leadership

Global regulatory knowledge

Cross-functional leadership

Regulatory consulting

Regulatory submissions

Ausbildung

Advanced degree (Masters/PhD)

Jobbeschreibung

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:

Vision

to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission

to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values

• 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.

$150,000.00

Job Description

• Lead the development and execution of global regulatory strategies for medical devices, in vitro diagnostics, combination products, and related technologies across all stages of product development.
• Serve as the primary regulatory consultant for clients, providing scientific, technical, and strategic guidance to support regulatory approvals, market access, and commercialization objectives.
• Prepare, review, and support regulatory submissions and interactions with health authorities and conformity assessment bodies, including FDA, Health Canada, and other global regulators.
• Develop and review regulatory assessments, technical documentation, clinical and preclinical strategies, testing plans, and supporting evidence packages.
• Lead cross-functional project teams and collaborate with clinical, quality, biostatistics, reimbursement, and laboratory experts to deliver integrated client solutions.
• Act as a trusted advisor to clients by interpreting regulatory requirements, assessing regulatory impact, and recommending practical, risk-based pathways to market.
• Manage multiple client engagements simultaneously, ensuring high-quality deliverables, adherence to timelines and budgets, and proactive communication of project risks and issues.
• Support business development activities by engaging with prospective clients, defining project scope, contributing to proposals, estimating effort, and identifying opportunities for additional NAMSA services.
• Mentor and coach consultants and other associates, providing technical leadership and contributing to the professional development of colleagues.
• Contribute to NAMSA's thought leadership through conference presentations, webinars, publications, standards participation, white papers, and other scientific or marketing initiatives.
• Drive continuous improvement of consulting processes, service delivery, and regulatory best practices across the organization.
• Maintain expert knowledge of global medical device regulations, standards, guidance documents, and industry trends to ensure clients receive current and effective regulatory advice.

Qualifications & Technical Competencies

• 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.

Working Conditions

• 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:

$101,600.00 - $197,500.00

Annual

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.

NAMSA Is An Equal Employment Opportunity Company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.