Senior Regulatory Affairs Specialist
ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Senior Regulatory Affairs Specialist position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Pennsylvania-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.
- Representing regulatory affairs on product development teams and providing the global regulatory plan, regulatory assessments, and regulatory decisions.
- Preparing regulatory documentation for devices, including IDE, 510(k), PMA, Technical File/Technical Documentation and Design Dossier documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
- Assisting in the preparation of approval documents to support rest of world registrations/approvals.
- Reviewing engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.
- Reviewing product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
- Assisting with the maintenance of the regulatory database(s) with accurate and current regulatory information.
- Providing Regulatory Affairs support during internal and external audits.
- Providing regulatory support during product nonconformance (NC) investigations and Corrective and Preventive Action (CAPA) activities.
Skills and Requirements:
- Bachelor's degree in a scientific field, though a Master's degree is preferred.
- A minimum of 4 years of regulatory affairs experience in medical devices, though a Master's degree will also be accepted, along with relevant medical device industry experience.
- Experience with FDA medical device regulations and guidance, including unique device identifier (UDI) regulatory requirements:
- EU MDD/MDR medical device regulations and guidelines
- Orthopaedic implants
- Canadian regulations and guidance
- MDALL database
- Electronic submission preparation
- Regulatory assessments for product changes
- Review of marketing/promotional materials
- Support for NC, CAPA, and audit related activities
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Maya Smith at +267-405-6995 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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