GRAIL

Global Regulatory Affairs, Associate Director – UK Regulations Focus (RTP, NC) #4132

DURHAM, NCPosted 30+ days ago

Job summary

  • Job post source

    This job is directly from GRAIL

  • Job overview

    The Global Regulatory Affairs Associate Director at GRAIL focuses on UK regulations to ensure compliance and support early cancer detection technologies.

  • Responsibilities and impact

    The role involves managing UK IVD medical device registrations, interfacing with MHRA and other regulatory bodies, supporting safety reporting, overseeing UKRP audits, and collaborating with cross-functional teams to maintain regulatory compliance.

  • Compensation and benefits

    The position offers an annual base pay of $142,000 to $178,000 depending on experience and location, eligibility for annual bonuses and long-term incentives, and a comprehensive benefits package including flexible time-off, 401k with company match, and medical, dental, vision, and mindfulness programs.

  • Experience and skills

    Candidates should have a BS with 12+ years or advanced degrees with equivalent experience, regulatory affairs experience in IVD, medical devices or pharma with UK and EU submission expertise, strong leadership, communication, and problem-solving skills, and preferably Regulatory Affairs Certification.

  • Work environment and culture

    GRAIL promotes an inclusive, equal opportunity work environment with accommodations for disabilities and a drug-free workplace, emphasizing collaboration and innovation in cancer detection.

  • Company information

    GRAIL is a healthcare company pioneering early cancer detection using next-generation sequencing and data science, headquartered in Menlo Park, CA, with global locations and backed by leading investors and partners.

  • Job location and travel

    The role is based in Durham, NC, with possible interactions with other GRAIL locations including the UK and Washington, D.C., supporting a multi-location work environment.

  • Unique job features

    This position uniquely combines regulatory leadership with direct interaction with UK regulatory authorities and involvement in innovative cancer detection technologies at a pioneering healthcare company.

Company overview

GRAIL is a healthcare company focused on early cancer detection through innovative blood tests. They make money by developing and selling their flagship product, Galleri, a multi-cancer early detection test that can identify over 50 types of cancer from a single blood draw. Founded in 2016, GRAIL has made significant strides in genomics and biotechnology, leveraging advanced sequencing technology and machine learning to analyze genetic data. Acquired by Illumina in 2021, GRAIL continues to expand its research and commercial efforts to transform cancer diagnostics and improve patient outcomes.

How to land this job

  • Tailor your resume to emphasize your extensive experience in regulatory affairs within the IVD, medical device, or pharmaceutical industries, focusing on UK and EU regulatory submissions and safety reporting.

  • Highlight your ability to interface with regulatory bodies such as MHRA and EU Notified Bodies, showcasing your communication skills and experience managing product registrations, audits, and compliance documentation.

  • Apply through multiple channels including GRAIL's corporate careers page and LinkedIn to maximize your application visibility and ensure your resume reaches the right hiring managers.

  • Connect with professionals in GRAIL's Regulatory Affairs or Quality divisions on LinkedIn; use ice breakers like commenting on recent MHRA regulatory updates or expressing interest in GRAIL's innovative cancer detection technologies to start meaningful conversations.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'UK Responsible Person (UKRP),' 'IVD product registrations,' 'MHRA,' 'regulatory submissions,' 'safety reporting,' and 'medical devices' to ensure it passes initial screening.

  • Use Jennie Johnson's Power Apply feature to automate multi-channel applications, tailor your resume for ATS, and identify LinkedIn contacts to network with, freeing up your time to prepare for interviews and deepen your industry knowledge.

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