Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Responsibilities:

Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in molding our regulatory strategies!

Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teamsDocument regulatory strategies for product submissions.Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assaysFacilitate FDA pre-submission meetingsPrepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assaysSupport EU representatives in their creation of CE/IVD Technical FilesSupport global regulatory registration representatives for product registration activitiesPerform regulatory assessment of new and changed products. Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.Conduct training and/or communicate appropriate materials, as needed, to improve the team’s knowledge of working in a regulated environment.Assist the Regulatory department in updating, improving, and crafting internal policies and procedures.Participate in business meetings with potential new external partnersRequirements:

To be successful in this role, you must possess proven experience in regulatory affairs, particularly within the legal framework. You should have:

B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related scienceAt least 5 years of IVD Regulatory Affairs experienceHands-on experience with 510(k), PMA, and PMA supplement submissionsDeep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirementsExperience as the RA representative on project core teamsStrong communication and teamwork skillsAbility to lead multiple projects and meet deadlinesCapacity to communicate regulations to technical functions within the companyWillingness to travel (10-15%)Comfort with ambiguity and change

Join us in this ambitious role and make a difference in global health and safety!

Compensation and Benefits

The salary range estimated for this position based in California is $103,100.00–$154,700.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards