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- The Senior Regulatory Affairs Specialist is expected to provide collaborative leadership within the Quality Assurance & Regulatory Compliance team as well as within the organization and global LBS teams as required.
- The Specialist will work with cross functional teams to bring IVD (In-Vitro Diagnostic), medical and chemical products to market and ensure ongoing compliance while continuing to develop regulatory affairs skills.
- This role will lead major regulatory efforts requiring cross-site partnership and execution.
- The Senior Regulatory Compliance Specialist will conduct improvements to standard work for product registrations, listings, and renewals globally. Strong problem solving and decision-making skills are expected to drive regulatory compliance efforts.
- The Senior Regulatory Compliance Specialist will drive the Danaher Business Systems (DBS) mindset to improve quality, processes, and innovation by applying tools and continuous improvement mind-set.
- Provide product regulatory strategy and registration guidance on New Product Development, Design Change and Sustaining projects.
- Identify pathways to market and requirements to sustain regulatory compliance for chemical products, IVD products and instrumentation.
- Prepare, review, and approve regulatory documentation for submission, including but not limited to Technical Files/Device Files and DoCs, to regulatory agencies or to commercial partners, advise on the submission strategy.
- Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
- Review and approve Marketing, Advertising, Promotional and Scientific Materials to ensure compliance with regulations in country/countries where materials are distributed.
- Provide subject matter expertise during internal and external site audits (i.e. MDSAP, GMP, etc.)
- Budget planning.
- Regulatory Affairs, IVD, Regulatory Strategy, Global Registration, Regulatory Submissions, FDA, GMP, ISO 13485:2016, Health Canada, Histology, Pathology, Medical Device.
- Regulatory Affairs,IVD,Regulatory Strategy,Global Registration.
Skills & Qualifications
- Education: Bachelor's Degree, preferably in Engineering or Life Sciences.
- 8+ years-experience within medical device/IVD; Histology/Pathology experience is a plus.
- FDA (Class I & II) and Health Canada regulatory knowledge including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence.
- Knowledge of chemical compliance regulations (i.e.: RoHS, TSCA, REACH etc.).
- Experience with ISO 13485:2016, IVD Regulations, FDA GMP, and domestic/international Medical Device Regulations.
- Experience with support of cross functional new product development from a RA perspective including risk management, review of technical files, product labels/IFU, new product approval and registration.
- Experience with Global Registrations and Change Control Desired Experience/Skills: RAC (Regulatory Affairs Certification) is a plus.
- Ability to identify, analyze and mitigate risk.
- Strong organizational skills.
- Strong communication skills and ability to explain difficult or sensitive information, works to build consensus.