Parexel Regulatory Affairs Consultant (Medical Device IVDR) Recruitment 2026: Apply Online

About the Role

Parexel is seeking a highly skilled and experienced Regulatory Affairs professional to join our dynamic team as a Regulatory Affairs Consultant, specializing in Medical Device IVDR. This pivotal role is designed for individuals who can provide expert guidance on regulatory pathways for performance evaluation studies and marketing authorizations for in vitro diagnostic devices. You will serve as the key regulatory representative for our global project teams, ensuring compliance and facilitating product approvals.

Key Responsibilities

• Develop comprehensive and effective regulatory strategies for performance evaluation studies of IVD products.
• Provide critical support in the preparation and compilation of technical documentation required for IVDs.
• Act as the primary regulatory affairs representative within global project teams and governance meetings, ensuring regulatory input is integrated effectively.
• Lead and manage all regulatory interactions with health authorities and notified bodies, including the preparation of necessary documentation and coordination of meetings.
• Oversee and manage regulatory activities throughout the entire IVD clinical development lifecycle, from initial studies to marketing authorization.
• Maintain global regulatory databases, ensuring all information is accurate, up-to-date, and compliant with relevant regulations.
• Collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Clinical Operations, to ensure timely and compliant regulatory submissions.
• Contribute actively to continuous improvement initiatives, fostering innovation and strategic planning within the regulatory function to enhance our service offerings.

Skills and Experience Required

• Education: A University degree in a scientific discipline, technical field, or life science degree is mandatory. Degrees in biopharmaceutical or bioscience-related fields are highly preferred.
• Experience: A minimum of 5 years of dedicated experience in regulatory affairs specifically for In Vitro Diagnostic (IVD) devices.
• Regulatory Knowledge: In-depth understanding and practical application of EU IVDR, ISO 13485, and ISO 20916 standards.
• Additional Knowledge: Familiarity with EU MDR regulation and international regulatory frameworks is considered a strong asset. Prior experience in the broader medical device sector is beneficial.
• Global Strategy: Proven track record in developing global regulatory strategies and preparing technical documentation for EU markets, including CE certifications.
• Audits & Inspections: Demonstrated success in representing companies during regulatory audits and inspections by health authorities.
• Communication Skills: Excellent verbal and written communication and interpersonal skills are essential for effective stakeholder engagement.
• Technical Proficiency: Proficiency with regulatory systems such as Veeva and TrackWise is a plus.

Why Join Parexel?

At Parexel, we are committed to bringing life-changing treatments to patients faster. As part of our team, you will have the opportunity to work on challenging and diverse projects, collaborate with a global network of experts, and enjoy the flexibility of working remotely while being part of a supportive and dynamic team. We value innovation, continuous learning, and a patient-centric approach in everything we do. This role offers significant opportunities for professional growth and development within a leading global clinical research organization.

Parexel is a leading global clinical research organization (CRO) dedicated to accelerating the development of innovative treatments for patients worldwide. We partner with pharmaceutical, biotechnology, and medical device companies to help them navigate the complex landscape of drug and device development, from early-phase research to post-market surveillance. Our mission is to improve the world of health by bringing life-changing therapies to patients faster and more efficiently. We foster a culture of collaboration, innovation, and patient-centricity, offering a dynamic and supportive environment for our employees to grow their careers.