Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager Oncology

Position Summary

The Senior Regulatory Affairs Manager will provide direct regulatory support for Oncology IVD/CDx products (Guardant360 CDx and future products such as Tissue IVD/CDx) in all stages of the product lifecycle. This role will actively lead and support development and implementation of regulatory strategies premarket submissions post-market submissions labeling review interactions with regulatory bodies and other related regulatory activities primarily for the US market. Responsibilities will include all aspects of product core team regulatory support including planning regulatory strategy technical document review preparation of submissions and interpretation of regulations and requirements.

This position is an individual contributor role with expectations to be hands-on and will report to the Sr. Director of Regulatory Affairs Oncology and will liaise closely with regulatory and cross-functional teams at Guardant Health to bring innovative cancer screening assays to market and keep them compliant.

Position level/title will depend on experience.

Essential Duties and Responsibilities

• Effectively prepare and manage FDA submissions including pre-market (PMAs Q-Subs IDEs BDDs SIRs) and post-market (sPMAs 30-Day notices Annual Reports) regulatory submissions in adherence with applicable regulations for submission to government agencies.
• Represent regulatory affairs in cross-functional project teams to support both new product development and on-market product support efforts.
• Actively review project and submission related documentation including analytical clinical V&V risk quality labeling and manufacturing.
• Support regulatory activities throughout product lifecycle and maintain registrations by ensuring regulatory compliance.
• Facilitate product approvals through effective communications and negotiations with regulatory agencies and project teams.
• Support the planning and execution of the regulatory strategic direction for the business.
• Responsible for managing regulatory workflow including prioritizing project deliverables and establishing timeframes for projects with cross-functional teams.
• Responsible for overseeing progress and completion of projects with project team members ensuring timeframes and deadlines are met.
• Lead and coordinate internal tracking authoring and review of responses to requests from regulatory agencies.
• Identify project risk and develop alternate strategies or contingency plans as mitigation.
• Provide strategic advice to the cross-functional team in response to their queries based on regulatory experience and area of expertise.
• Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers advising on regulatory issues and strategies.
• Provide updates to project teams and management regarding regulatory status and requirements of company products.

Qualifications :

Qualifications

• Bachelors degree in Life Sciences Engineering or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role preferably in molecular diagnostics or closely related area; OR an advanced degree with at least 5 years of relevant experience in an IVD/CDx regulatory affairs role. Alternatively at least 3 years reviewing molecular diagnostic devices with the FDA.
• Proven success in authoring and leading FDA regulatory submissions and interactions including PMAs sPMAs 30-Day Notices 510(k)s and IDE submissions.
• Strong working knowledge of IVD/CDx and/or medical device development processes including design control change control and Quality Systems.
• Proven ability to independently manage the preparation and coordination of premarket and post-market regulatory submissions.
• Successful track record of securing and maintaining product approvals and registrations through effective cross-functional coordination and strategic problem solving.
• Awareness of and experience navigating regulatory issues and challenges associated with diagnostic and/or IVD/CDx development.
• Excellent analytical skills with high attention to detail.
• Strong written and verbal communication skills with the ability to convey complex issues in a straightforward manner.
• Highly organized and capable of managing multiple priorities across complex projects in a fast-paced environment.
• Self-motivated and able to work independently and collaboratively with minimal supervision.
• Hands-on proactive and solutions-oriented with strong negotiation and interpersonal skills.
• Proficient with Microsoft Office Propel JIRA Teams Confluence and AI tools is a plus.

Additional Information :

Hybrid Work Model: At Guardant Health we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays Tuesdays and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The US base salary range for this full-time position is $148600 to $203660. The range does not include benefits and if applicable bonus commission or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

Within the range individual pay is determined by work location and additional factors including but not limited to job-related skills experience and relevant education or training. If you are selected to move forward the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however there may be exposure to high noise levels fumes and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities long-term conditions mental health conditions or sincerely held religious beliefs. If you need support please reach out to 

A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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