• Regulatory Affairs Specialist III

    ThermoFisher Scientific (Rochester, NY)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Office

    Job Description

    Ready for a key role ensuring products meet top standards at Thermo Fisher Scientific Inc.?

    Key Responsibilities

    + Complete divisional raw material and product compliance strategies.

    + Collaborate with Corporate Product Compliance team on regulatory changes and implementing tools like Greensoft for REACH/SVHC, California Proposition 65, and RoHS compliance.

    + Mentor others on regulatory requirements.

    + Support product development by facilitating globally focused regulatory strategies to drive market access.

    + Draft regulatory plans and verification reports to ensure products meet regulatory requirements in all target market regions.

    + Assess product and material compliance with regulations, providing clear rationale and documentation.

    + Support material change risk assessments and verify product claims align with global industry standards (ISO 10993, USP, Pharm Eur, ICH food contact, BSE/TSE, etc).

    + Review and approve product development reports, non-conformance reports, product changes, and new product data entry.

    + Provide customer regulatory support for compliance requests and resolve product non-conformities, product complaints, and CAPA’s.

    + Be a role model leader by exhibiting behavior in conformance with the Thermo Fisher Code of Ethics and demonstrating our 4-I values (integrity, intensity, involvement, and innovation).

    Successful Candidate Will Possess

    + A positive approach and motivated by challenges

    + Team-player mentality

    + Dedicated with the ability to handle tasks independently

    + Flexibility to handle shifting priorities

    + Confidence in collaborating with colleagues at all levels

    + Strong written communication skills, with technical writing experience being a plus

    + Excellent critical thinking and decision-making skills

    + A continuous improvement approach

    + Innovative problem-solving ability

    + Strong organizational skills with attention to detail

    Education and Experience Requirements

    + Minimum BA/BS degree in a scientific or engineering field (preferred: material science, polymer science, biology, or chemistry).

    + At least 2 years of experience in a regulated industry (pharmaceutical or medical device).

    Preferred Qualifications

    + Familiarity with product stewardship, product support, and development processes.

    + Basic knowledge of polymer chemistry and environmental material compliance regulations (EU REACH, CA Prop 65, TSCA).

    + Understanding of pharmaceutical and medical device standards and regulations (USP, ISO 10993, ISO 13485, IVDR, MDR).

    + Experience with risk management principles (ISO 14971) and drafting protocols, reports, and procedures (SOPs).

    + Knowledge of systems like SAP, Salesforce.com, Trackwise, Oracle, and Agile.

     

    Join us in making a difference and ensuring our products meet the highest standards for regulatory compliance!

     

    Compensation and Benefits

     

    The salary range estimated for this position based in New York is $75,800.00–$113,675.00.

     

    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.