Regulatory Affairs Manager
Regulatory Affairs Manager
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$ 103100 - 154700
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 PreSubmission documents for Next Generation Sequencing and/or PCR assays
- Facilitate FDA presubmission 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 teams 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:
- . or equivalent experience in Biology Chemistry bioengineering or related science
- At least 5 years of IVD Regulatory Affairs experience
- Handson 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 1015
- 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 $103100.00$154700.00.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 longterm 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: Experience:
Manager
Employment Type
Full-Time
Key Skills
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