Regulatory Affairs Specialist III

Work Schedule

Environmental Conditions

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 CAPAs.
• 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 Trackwise Oracle and Agile.

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

Compensation and Benefits

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: Experience:

Unclear Seniority