Regulatory Affairs, Associate Director (PMA Submissions)

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
Feb 14, 2021
Ref
384412545
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA 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 www.grail.com.

The ideal candidate will be a strong regulatory partner to the Product Development and Business Teams. Will lead the organization in the development of submissions for product registrations, progress reports, supplements, amendments, and/or periodic experience reports etc. Provides strategic product direction to teams and negotiates with regulatory agencies to expedite approval of IVD product registrations. Monitors and communicates regulatory strategy and changes in regulatory requirements to project teams and leadership. May manage, lead and provide direction to Regulatory Staff and when required participate in Senior Management meetings as a delegate. Develops and drives a work culture committed to compliance, quality and customer focus.

You will:

• Develop proactive approaches for regulatory activities to meet business requirements.
• Manages submission activities for a variety of device regulatory submissions and approvals including US premarket approvals (PMAs), US premarket notifications (510(k)s), IDEs, post-approval reports, annual reports, export certificates, and establishment registrations, device listings.
• May serve as a key member of the Regulatory Leadership team providing insights, solutions and direction on general business and product portfolio matters. Provides regulatory support to new and currently marketed products, e.g., labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
• Review, interpret, and report to Regulatory leadership on product specific regulatory issues that may have material impact on the business or the customer.
• Work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
• Lead the identification of regulatory risk areas and develop alternative courses of action.
• Assess the impact of new regulations and work with the Organization to implement appropriate changes.
• Represent GRAIL during communications and meetings with Health Authorities and interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
• Ensure compliance with regulations and laws pertaining to the GRAIL business and provides guidance and advice.
• Independently review and approve Regulatory Strategy Documents, Regulatory Plans, procedures, SOPs and other documentation with respect to commitments, regulations and filingsManages the development and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
• Provides regulatory support on project teamsServes as a functional lead on project teamsProvides consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issuesIf required, responsible for managing indirect and direct reports which includes, but is not limited to, hiring/firing decisions, selection, performance feedback, discipline, pay decisions, and handling employee's grievances/complaints.
• Performs other duties as required or assigned

Your background should include:

• B.S./B.A. in a science or related life science field; advanced degree preferred.
• Minimum of 8 years' experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. (IVD device experience is preferred )
• Regulatory affairs experience (certification preferred)
• Advanced scientific degree counts toward years of experience and is a plus
• Demonstrated knowledge of regulations and procedures required for development of new medical devices, submission of applications to the FDA and OUS (outside US) health authorities for approval to market new medical devices.
• Experience with regulatory submissions for Q-submission, IDE, 510(k), PMA and CE Mark Experience with quality system and software development.
• 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.
• Ability to work in a fast-paced/entrepreneurial team environment.
• Excellent oral and written communication skills.
• Strong organizational skills and attention to detail required.
• Experience in diagnostics or biomarker development with emphasis on oncology a plus
• Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus
• Ability to travel up to 25% of the time.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.