Regulatory Affairs Manager

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 teams
• Document regulatory strategies for product submissions.
• Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
• Facilitate FDA pre-submission meetings
• Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
• Support EU representatives in their creation of CE/IVD Technical Files
• Support global regulatory registration representatives for product registration activities
• Perform 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 partners
• Requirements:

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 science
• At least 5 years of IVD Regulatory Affairs experience
• Hands-on experience with 510(k), PMA, and PMA supplement submissions
• Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
• Experience as the RA representative on project core teams
• Strong communication and teamwork skills
• Ability to lead multiple projects and meet deadlines
• Capacity to communicate regulations to technical functions within the company
• Willingness 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