Senior Regulatory Consultant

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Lead the creation and implementation of global regulatory strategies for medical devices, in vitro diagnostics, combination products, and associated technologies throughout all stages of product development.

• Act as the primary regulatory advisor for clients, offering scientific, technical, and strategic insights to facilitate regulatory approvals, market access, and commercialization goals.

• Prepare, review, and assist with regulatory submissions and communications with health authorities and conformity assessment organizations, including FDA, Health Canada, and other international regulators.

• Develop and evaluate regulatory assessments, technical documentation, clinical and preclinical strategies, testing plans, and supporting evidence packages.

• Lead interdisciplinary project teams and collaborate with clinical, quality, biostatistics, reimbursement, and laboratory experts to provide comprehensive client solutions.

• Interpret regulatory requirements, evaluate regulatory impact, and propose practical, risk-based pathways to market.

• Manage multiple client projects concurrently, ensuring high-quality deliverables, adherence to timelines and budgets, and proactive communication of project risks and challenges.

• Assist in business development initiatives by engaging with potential clients, defining project scopes, contributing to proposals, estimating efforts, and identifying opportunities for additional NAMSA services.

• Mentor and coach consultants and associates, offering technical leadership and aiding in the professional growth of colleagues.

• Contribute to NAMSA's thought leadership through conference presentations, webinars, publications, standards participation, white papers, and various scientific or marketing initiatives.

• Propel continuous enhancement of consulting processes, service delivery, and regulatory best practices.

• Maintain expert knowledge of global medical device regulations, standards, guidance documents, and industry trends.

• Travel approximately 5 to 10% of the time.

⛳️ Requirements

• 7+ years of experience in medical device regulation, including strategic leadership of product development programs.

• Previous experience with FDA, regulatory authorities, or the medical device industry is mandatory.

• Expertise in one or more fields, such as regulatory affairs, clinical strategy, non-clinical testing, engineering, combination products, or IVDs.

• Strong understanding of global medical device regulations, standards, and quality systems, including FDA, EU MDR/IVDR, ISO 13485, MDSAP, GCP, GLP, GMP, NMPA, and PMDA.

• Proven ability to formulate regulatory strategies, evaluate regulatory impact, and support interactions with global regulatory agencies.

• Excellent analytical, problem-solving, communication, writing, and presentation abilities.

• Capability to lead cross-functional teams, juggle multiple priorities, and deliver high-quality outcomes within set timelines and budgets.

• Commitment to ongoing learning and professional development in emerging regulatory and industry subjects.

• An advanced degree (Master's, PhD, or equivalent) in science, engineering, business, or a related field is preferred.

🏝️ Benefits

• Opportunities for professional development and continuous learning.

• Mentoring and coaching prospects.

• Reasonable accommodations for individuals with disabilities.

• Equal employment opportunity.

• Pre-employment background checks and drug screening processes in accordance with local, state, and federal regulations.