This role provides strategic regulatory and clinical leadership to cross-functional development teams, supporting global pre-market submissions and driving timelines for new and evolving medical technologies. The position demands a proactive, detail-oriented professional with strong organizational and time management capabilities.Key ResponsibilitiesPrepare international regulatory submissions (e.g., CE and FDA IDE), including associated risk documentation and clinical safety assessments.Lead regulatory input for emerging products, providing day-to-day support throughout design and development phases.Evaluate change controls for potential regulatory impact and required filings.Manage post-market surveillance and vigilance activities in compliance with global regulatory requirements.Fulfill obligations as the Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15 (EU Regulation 2017/745).Plan and coordinate regulatory and clinical strategies, incorporating ongoing improvement initiatives that align with evolving product portfolios.Represent the organization in external engagements with research partners, clinical sites, thought leaders, and contract research organizations.Guide and support the development and publication of clinical research, including study design, site selection, execution oversight, data analysis, and manuscript preparation.Ensure all regulatory and clinical operations uphold the highest ethical standards.Develop, implement, and maintain policies and processes to ensure regulatory compliance across regional and global health authorities.Author, review, and manage submissions to global regulators, including assessments of product updates and lifecycle changes.Define submission strategies and lead communication with regulatory agencies worldwide, including U.S. FDA and international health bodies.Oversee the preparation and approval of product labelling, packaging, and promotional claims from a regulatory standpoint.Provide regulatory support in project planning for product development and commercialization.Monitor and interpret relevant regulatory publications and legislation across local, regional, and international levels.Collaborate with internal commercial teams and external distribution partners to support and maintain country-specific product registrations.BackgroundDegree qualified in a scientific, clinical, or regulatory discipline.Minimum 5 years’ experience in Regulatory Affairs and/or Clinical Affairs within the medical device or healthcare technology sector.Demonstrated success in driving product approvals and navigating regulatory pathways for innovative medical technologies.Deep understanding of international medical device regulations (including FDA and ISO standards) with the ability to translate requirements into actionable system improvements.Strong analytical and technical writing skills, with experience producing high-quality documentation to support submissions.Proven ability to assess and address gaps in technical and clinical data.Effective communicator with experience engaging regulatory authorities and managing inspections.Collaborative team player with strong interpersonal skills and a solution-focused mindset.Seniority LevelDirectorEmployment TypeFull-timeJob FunctionQuality AssuranceIndustriesMedical Equipment Manufacturing
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