• Regulatory Affairs Manager

    ThermoFisher Scientific (Austin, TX)


    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

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.