Overview
As a Regulatory Affairs professional, you will lead regulatory strategy for medical devices and drug-device combinations. You will serve as the regulatory representative for global project teams and drive interactions with health authorities and Notified Bodies. You will oversee regulatory activities across the device development lifecycle and ensure compliant submissions. This role supports Parexel’s mission to improve world health by enabling patient access to therapies. You will work across regions, including EU MDR-focused tasks, in a flexible home/office setup.
Responsabilità
- Develop regulatory strategies and create technical documentation for medical devices and combination products
- Represent regulatory affairs in global project teams and governance meetings
- Lead interactions with health authorities and Notified Bodies, including documentation and meeting coordination
- Manage regulatory activities throughout device clinical development and marketing authorization lifecycle
- Maintain global regulatory databases with up-to-date information
- Collaborate with CMC and QA on device change control and global submission requirements
- Support internal and external audits related to medical device quality systems
- Coordinate with cross-functional teams to ensure timely, compliant regulatory submissions
- Contribute to continuous improvement, innovation, and strategic planning within regulatory function
Requisiti fondamentali
- University degree in a scientific discipline or life sciences field; minimum 5+ years of regulatory affairs experience for medical devices and drug-device combinations
- In-depth knowledge of global medical device regulations, especially EU MDR; familiarity with US FDA is a plus
- Proven experience in global regulatory strategy and technical documentation for EU (clinical investigations, Notified Body opinions, CE certifications)
- Familiarity with EU-MDR, ISO 13485, ISO 14155; experience with in vitro diagnostic devices a plus
- Strong track record in regulatory audits and inspections; excellent communication and interpersonal skills
- Fluent in English, written and spoken
- Proficiency with regulatory systems like Veeva and TrackWise a plus
- Excellent communication and interpersonal skills
- Cross-functional collaboration
- audit and inspection readiness
- Regulatory strategy for medical devices and combination products
- Regulatory documentation for EU and Notified Bodies
- EU MDR knowledge
Regulatory Affairs Consultant: Medical Device and Combination Product Expert datore di lavoro: Parexel
La nostra azienda è un datore di lavoro eccezionale, offrendo un ambiente di lavoro stimolante e collaborativo per i professionisti delle affari regolatori nel settore dei dispositivi medici. Con opportunità di crescita professionale e un forte impegno per l'innovazione, i dipendenti possono contribuire attivamente a strategie globali mentre lavorano in diverse località europee, sia da casa che in ufficio. Inoltre, la cultura aziendale promuove il supporto reciproco e il miglioramento continuo, rendendo ogni giorno significativo e gratificante.
