Regulatory Affairs Consultant – Medical Device, Combination Product Expert
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Job Description
Regulatory Affairs Consultant leading medical device regulatory strategies for Parexel. Providing guidance on regulatory pathways and serving as the key regulatory representative for global teams.
Responsibilities:
- Develop comprehensive regulatory strategies and technical documentation of medical devices and combination products
- Represent the regulatory affairs function in global project teams and governance meetings
- Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings
- Manage regulatory activities throughout the device clinical development lifecycle and marketing authorization
- Maintain global regulatory databases with accurate and current information
- Collaborate with CMC and QA departments on device change control processes and global submission requirements
- Support internal and external audits related to medical device quality systems
- Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions
- Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function
Requirements:
- University degree in a scientific discipline, technical or life science degree required
- Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combination products
- In-depth knowledge of global medical device regulations, in particular EU MDR
- Knowledge of US FDA regulation would be a plus
- Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., clinical investigations, Notified Body opinions, CE certifications)
- Familiarity with medical devices regulatory framework including EU-MDR, ISO 13485 and ISO 14155
- Experience also in vitro diagnostic devices would be a plus
- Strong track record representing companies during regulatory audits and inspections
- Excellent communication and interpersonal skills
- Fluent in English, written and spoken
- Proficiency with regulatory systems including Veeva and TrackWise would be a plus.
Benefits:
- Flexible work arrangements
- Professional development
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