Regulatory Affairs Manager

Thermo Fisher Scientific; Guilford (CT); On-site; USD 103,000 - 155,000; Full time

Job summary

Join a forward-thinking company as a Manager in Regulatory Affairs, where you will shape regulatory strategies that impact global health. This pivotal role involves guiding project teams, preparing crucial regulatory submissions, and ensuring compliance with evolving regulations. With a focus on collaboration, you'll work closely with internal teams and external partners to drive successful outcomes. Enjoy a competitive salary, comprehensive benefits, and the opportunity to make a significant difference in the field of health and safety. If you're ready to lead in a dynamic environment, this role is for you!

Benefits

National medical and dental plans

Employee assistance and family support programs

Paid time off (PTO)

401(k) retirement savings plan

Employee Stock Purchase Plan (ESPP)

Qualifications

• 5+ years of IVD Regulatory Affairs experience.
• Hands-on experience with 510(k), PMA, and PMA submissions.

Responsibilities

• Provide regulatory guidance to project teams and external partners.
• Prepare U.S. regulatory submissions for Next Generation Sequencing.

Skills

Regulatory Affairs

Communication Skills

Project Management

Teamwork

Knowledge of cGMP/Quality Systems

Education

B.Sc. in Biology

B.Sc. in Chemistry

B.Sc. in Bioengineering

Job description

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