Global Regulatory Affairs Associate Director (UK Specific Regulations) - RTP or DC based #4132

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit grail.com.

The Associate Director of Global Regulatory Affairs & Safety serves as a key point of contact for GRAIL’s UK Responsible Person (UKRP). Interfaces with MHRA and other International regulatory agencies, Notified Bodies, and external consultants as needed, on IVD product registrations and audits. Supports US regulatory team and partners with Quality, and relevant cross-functional stakeholders to support UKRP audits, review of promotional material, on-market product support. Creates processes to ensure UKRP functions are adequately performed following procedures and protocols. Monitors and communicates changes in UK and International IVD requirements to project teams and leadership. May be required to manage, lead and provide direction to Regulatory Staff and participate in Senior Management meetings as a delegate. 

Responsibilities:

• Be responsible for ensuring electronic registration of  GRAIL IVD medical devices compliant with the applicable Regulations and Annexes in the Database of the MHRA and similar processes in other assigned jurisdictions as required.
• Represent GRAIL during communications and meetings with MHRA and interfaces with regulatory authorities on regulatory and technical matters, as appropriate. Point of contact for any inquiries/requests from MHRA for supporting product documentation or any other administrative information.
• Ensures that UK specific declaration of conformity and technical documentation created by the manufacturer are available and, as needed, can be provided to MHRA.
• Be responsible for reporting safety events to the MORE database if needed and/or submitting reports in other assigned jurisdictions  as required.
• Support the legal manufacturer (GRAIL US) in preparation and delivery of required regulatory reports, e.g. annual reports to the MHRA according to regulatory reporting timelines for marketed products in assigned jurisdictions. 
• Supporting/planning/contributing to processes for safety data collection of marketed products in the UK including oversight of processes for data collection from external vendors/distributors/other sources as applicable. 
• If required, responsible for managing indirect and direct reports
• Performs other duties as required or assigned.

Preferred Qualifications:

• Ideal candidate will have BS/BA with 12+ years OR a Master’s with 10+ years OR a PhD + 8+ years of experience or equivalent
• Experience of working in IVD, medical device, or pharma industries in regulatory affairs/quality roles with experience of regulatory submissions and safety. IVD device experience is preferred.
• Experience with regulatory support and submissions in the UK and EU are essential.
• Experience in diagnostics or biomarker development with emphasis on oncology is a plus. 
• Advanced scientific degree a plus. 
• Regulatory Affairs Certification preferred.
• Track record of leadership, providing sound judgment/ideas and business partnering.
• Demonstrated knowledge of regulations and procedures required for the development of new medical devices, submission of applications to International health authorities and FDA for approval to market new medical devices. 
• Demonstrated ability to effectively present information to senior management and to regulatory agencies (including MHRA, EU Notified Bodies).
• Strong interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations.
• Ability to interpret and respond to requests from regulatory agencies and to work in a fast-paced/entrepreneurial team environment. 
• Excellent oral and written communication skills. Strong organizational skills and attention to detail required. 

The expected, full-time, annual base pay scale for this position is $142,000 - 178,000 for Durham, NC.  Actual base pay will consider skills, experience, and location.

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.