GRA Device Associate

Main Responsibilities

Partner with the Device Regulatory Lead on assigned projects.

Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams.

Contribute to and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part of combination products elements.

Contribute to device Health Authority interactions plan, support device related and cross-functional health authority interactions

Identifies medical devices regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT.

Identify issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.

Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions

Liaises with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes.

Prepare and review design control deliverables.

Contribute to product development and lifecycle management planning.

Provide regulatory impact assessments for proposed product changes.

May serve as a regional/local regulatory lead and point of contact with medical devices Health Authorities for projects/products in their remit, as needed.

Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management.

Contribute to internal regulatory processes and procedures for device/IVD.

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Why Choose Us

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

Help improve the lives of millions of people globally by making drug development quicker and more effective.

Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.