Job Description
Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description Join our team and make a difference by aiding customers in finding cures for cancer, protecting the environment, or ensuring food safety. Your work will have a tangible impact, and we will support your career ambitions!
How will you make an impact? Thermo Fisher is hiring a Regulatory Affairs Manager for in vitro diagnostics. They will provide support to In-Vitro Diagnostic core teams and can work in Carlsbad, CA, Frederick, MD, or Austin, TX. The manager will handle regulatory activities including drafting and reviewing sPMA's, pre-submissions, and other filings. They will also assist with publishing, document legalization, and communication with regulatory agencies.
What will you do?- Responsible for the delivery of regulatory mentorship to project teams and external partners.
- Prepare, collect, or coordinate information and prepare regulatory documentation for submission to regulatory agencies or commercial partners
- Perform regulatory assessments of new and changed products
- Provide regulatory support to existing and new cross-functional product teams and serve as the regulatory core team lead for companion diagnostic programs and other new products.
- Participate in project activities and review key project documents such as product design protocols related to verification and validation, risk assessment, etc.
- Author 510(k), PMA, PMA supplement, and pre submissions.
- Help prepare ex-US registrations and work with Regulatory Affairs colleagues in other regions to provide registration documents for IVD products promptly.
- Stay ahead of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- Assist Regulatory department in the update, improvement, and creation of internal policies and procedures.
- Legalize documents as requested to support international colleagues.
Job Location:
This is a Hybrid role 3 days a week for the locations of Carlsbad, CA, Austin, TX, South San Francisco, CA, or Frederick, MD.
How will you get here?- A minimum B.S. degree in Biology, Chemistry, bio-engineering or a related science, or equivalent experience.
Experience: - A minimum of 4 years within a technical environment; Regulatory Affairs, Quality Assurance, Software/System engineering, or R&D experience preferred.
- Must have familiarity in the aspects of regulatory submissions, design control, and cGMP/Quality Systems.
- Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
- Understanding of US FDA regulations and submission requirements related to medical devices including IVD products.
- Previous experience authoring regulatory filings and pre-submissions preferred.
- Capacity to communicate regulations to technical functions within the company.
- Ability to communicate with regulatory agencies and lead FDA meetings.
Required Qualifications: - Excellent communicator
- Hands-on, productive, and able to implement effectively through their team
- Continuous improvement-minded; familiar with balancing the need for quality and efficiency
- Able to work autonomously in a matrix-managed organization
- Ability to travel (~10-15%)
- Able to deal with ambiguity and change
This position does not have allocation for relocation.
Compensation and Benefits The salary range estimated for this position based in California is $100,000 - $137,000.
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 support programs, including commuter benefits and tuition reimbursement
- You'll receive generous benefits including 120 hours of paid time off, 10 paid holidays, parental leave, insurance, and disability coverage as per company policy.
- Options for retirement and savings programs, including a robust 401(k) U.S. plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.
We provide a comprehensive compensation package, including salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement, and a range of other employee benefits! We cultivate an engaging company culture that promotes innovation, forward-thinking, and offers excellent career and development opportunities.
For more information on our benefits, please visit: 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:
Job Tags
Holiday work, Temporary work, Relocation, 3 days per week,