Regulatory Affairs Manager – Medical Devices
hace 4 días
Barcelona
Position: Regulatory Affairs Manager – Medical Devices Level: Mid-level Type: Internal, Full-time Location: Austria / Spain (work permit provided for non-EU employees, must be willing to relocate) Job description: This is a full-time role for a Regulatory Affairs Manager with flexible location based in Austria or Spain. The position will offer the opportunity to work with a global cross-functional team, supporting medical device design stage initiatives while gaining exposure to various technologies. The role will involve in-person and/or remote collaboration as needed according to assigned projects. The Regulatory Affairs Manager will own and contribute to comprehensive design initiatives across the full product life cycle. Main Responsibilities: • Formulate regulatory strategy and project planning for medical device registrations., • Conduct product evaluation and classification, identify applicable global requirements and international standards., • Serve as the Regulatory and Quality SME for product development projects across all design stages, collaborating with subject matter experts and providing input to DHF documents. Contribute as the Regulatory expert during phase reviews., • Author US FDA and EU Technical Documentation for CE marking., • Lead global first-time registrations and renewals (e.g., Latin America, Emerging markets, Canada, Australia)., • Provide regulatory input to product labeling, marketing and training materials for global compliance., • Lead project-specific early communication with authorities (e.g., FDA Q-Submissions) and manage inquiries during submission reviews., • Support Post-Market Surveillance activities., • Conduct product design change assessment review and impact evaluation., • Support clients during audits for Medical Device Single Audit Program (MDSAP), FDA, ISO 13485, CE marking, and other region-specific authorities., • Support in Quality Management System implementation and maintenance, including drafting and updating standard operating procedures., • Work with common word processing, spreadsheet, and collaborative tools (e.g., Microsoft Office), and present online in video conferences. Candidate profile and required qualifications: • Relevant Experience: a minimum of 5 years within the medical device or pharmaceutical industry is required (e.g., developing medical devices, SaMD, combination products, IVDs)., • Studies: BS, MS, or PhD. in a field applicable to life science or international policy., • Experience working with cross-functional teams in medical device development from concept to market launch., • Direct experience as a subject matter expert responsible for authoring regulatory documentation for US and EU submissions. Experience with additional territories is a plus (e.g., Canada, Australia/NZ, LATAM, APAC, Emerging Markets)., • Self-directed, works independently in a remote setting and as part of a team., • Demonstrates excellent interpersonal skills, working with diverse groups of people in a global arena., • Ability to drive decisions, promote progress, and manage multiple projects., • Offers strategic and practical solutions to development team, presenting findings in concise and clear manner., • Interested in gaining experience in multiple key roles of medical device development, across various technologies., • Language Requirements: English – Full proficiency reading/writing., • If applicable, willing to relocate - flexible location residing in Austria or Spain. What we offer • One of the best overall career opportunities in the sector, • Rapid learning and development opportunities on a global scale, • Very competitive salary/bonus, • 5 weeks vacation + local holidays, • Optimal work-life balance with a company policy and management approach designed for sustainable career satisfaction, • Health insurance and a culture geared toward health and well-being, • An amazing collaborative team that is diverse, talented, and ready to celebrate success, • Fun fact: we come from 7 different countries and 4 continents About our company: Suma Medtec accelerates development projects for medical device and pharmaceutical manufacturers of all sizes. We support all aspects of product development and commercialization, with specialized competencies in Global Regulatory Affairs, Risk Management, Human Factors, Project Management, R&D Engineering, and Quality. For additional information about Suma Medtec, we invite you to visit our website: Suma Medtec GmbH is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage applications from candidates of all backgrounds, experiences, and perspectives. Please note that applications received through third-party staffing or recruiting companies will not be considered.
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