Job title: GRA Device Associate - Medical Devices and Combination Products (Senior Manager)

• Location: Morristown, NJ

About the Job

As GRA Device Associate in the GRA Device General Medicine and Vaccine Medical Device and Combination Product team you’ll contribute to global regulatory strategies for medical device and combination products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and influence the success of product approvals through strategic negotiations with health authorities worldwide. Ready to get started?

The GRA Device Associate role offers the opportunity to support a wide range of combination products, from pre-filled syringes, pen injectors, autoinjectors, large volume devices and other innovative technologies. Working at the intersection of science and compliance, you'll propose device strategies, conduct risk assessments, and interact with regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide.

About You

Education:

• Bachelor's degree in a scientific or engineering discipline.

• Advanced degree (Master or PhD) preferred.

Experience:

• 6+ years of relevant pharmaceutical OR biotechnology OR medical device industry experience.

• 3+ years of regulatory experience (combination of CMC, device, and combination product) with contributions to regulatory filings and implementation of regulatory strategies. 

• Experience responding to Health Authority questions.

Soft and Technical Skills:

• Familiarity with implementing device regulatory strategies to support product development, clinical use, and commercialization, including change controls.

• Familiarity with preparing regulatory documentation and standard submission processes.

• Understanding of drug clinical development, device development (including design controls), and working knowledge with technical/industry standards related to medical devices.

• Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams.

• Demonstrates business acumen, strong leadership, influencing, and persuasive negotiation skills.

• Demonstrates strategic thinking, initiative, change agent leadership, and risk assessment proficiency, including the ability to integrate overall business objectives into actionable project strategies.

​Language:

Strong written and verbal communication and influencing skills, with fluency in English.

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.

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.