Regulatory Affairs Consultant Medical Device IVDR home or office based in various EU locations

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

About the Role:

We are seeking an experienced Regulatory Affairs professional to lead IVD (in vitro diagnostic devices) regulatory this pivotal role you will provide expert guidance on regulatory pathways for performance evaluation studies and marketing authorizations and serve as the key regulatory representative for our global project teams.

The role can be home or office based in various European locations.

Key Responsibilities:

• Develop comprehensive regulatory strategies for performance evaluation studies.
• Support the preparation of technical documentation of IVDs 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 IVD clinical development lifecycle and marketing authorization.
• Maintain global regulatory databases with accurate and current information.
• 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.

Skills and Experience:

• University degree in a scientific discipline technical or life science degree required biopharmaceutical bioscience related science discipline.
• Minimum 5 years of experience in regulatory affairs for IVD.
• In-depth knowledge of EU IVDR ISO 13485 and ISO 20916.
• Knowledge of EU MDR regulation international regulatory framework and experience in medical devices would be a plus.
• Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g. performance evaluation studies CE certifications).
• 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.