Auf einen Blick
- Aufgaben: Leite die regulatorischen Prozesse für innovative Produkte und sorge für deren Marktzulassung.
- Unternehmen: Führendes Unternehmen in der Medizintechnik mit einem dynamischen Team.
- Vorteile: Attraktives Gehalt, Weiterbildungsmöglichkeiten und flexible Arbeitszeiten.
- Weitere Informationen: Reisebereitschaft von bis zu 10% für internationale Projekte.
- Warum dieser Job: Gestalte die Zukunft der Medizintechnik und arbeite an spannenden Projekten.
- Qualifikationen: Bachelor-Abschluss und 6 Jahre Erfahrung im Bereich Regulatory Affairs.
Das prognostizierte Gehalt liegt zwischen 60000 - 80000 € pro Jahr.
Responsibilities
- Provides independent regulatory guidance to product development teams in strategic planning, pre‑marketing, and related submissions to support optimal timelines for new or modified product launches.
- Manages the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
- Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Defines data and information needed for regulatory approvals.
- Develops labeling specifications and approves proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
- Plans schedules for regulatory deliverables on a project and monitors the project through completion.
- Leads the development of best practices for Regulatory Affairs processes.
- Represents Regulatory Affairs on cross‑functional project teams.
- Partners with other functions to define and obtain data to assist with regulatory submissions.
- May work with International Affiliates directly.
- Provides Regulatory Affairs support during internal and external audits.
- Communicates business‑related issues or opportunities to the next management level.
- Follows all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For supervisors or managers, ensures that subordinates follow all Company guidelines related to Health, Safety and Environmental practices, and that all necessary resources are available and in good condition.
- Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
Requirements
- Bachelor’s degree or equivalent.
- 6 years of related experience.
- Experience in the Medical Device industry or medical field.
- Experience with power devices is highly preferred.
- Demonstrated knowledge of US and EU Medical Device Regulations preferred.
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society or advanced degree in Regulatory Affairs, desirable.
- Ability to travel up to 10% internationally and domestically may be required.
- Core Competencies
Demonstrates expertise in Regulatory Affairs, including guidance on product development, compliance with US and EU Medical Device Regulations, and management of regulatory submissions.
Proven ability to lead cross‑functional teams and develop best practices for regulatory processes.
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Regulatory Affairs Manager Arbeitgeber: Jobtailor
Als Global Director B2B – Business Development bei uns profitieren Sie von einer dynamischen und innovativen Arbeitsumgebung, die auf Zusammenarbeit und Kreativität setzt. Wir bieten Ihnen nicht nur attraktive Vergütungsmodelle und umfassende Weiterbildungsmöglichkeiten, sondern auch die Chance, in einem internationalen Team zu arbeiten, das Vielfalt und persönliche Entwicklung fördert. Unsere Unternehmenskultur legt großen Wert auf Flexibilität und Work-Life-Balance, sodass Sie Ihre Karriereziele in einem unterstützenden Umfeld erreichen können.
