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 Responsibilities
* Prepare 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.
Background
* Degree 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 Level
Director
Employment Type
Full-time
Job Function
Quality Assurance
Industries
Medical Equipment Manufacturing
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