• Regulatory Affairs Specialist III

    ThermoFisher Scientific (Fremont, CA)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Office

    Job Description

    The Niche Diagnostics (NDX) business provides toxicology and quality control products. NDX is the leader in drugs of abuse testing and therapeutic drug monitoring, leading the market in screening, with the most widely used detection technology and a comprehensive menu of high-performing tests. Additionally, the NDX business is a market leader third-party quality controls and standards for clinical chemistry, immunoassay, molecular and sequencing tests.

     

    How will you make an impact?

     

    The Regulatory Affairs (RA) Specialist is responsible for providing technical support to regulatory affairs management to ensure continuous compliance with domestic and international regulatory requirements. The RA Specialist will be responsible for supporting global product registrations, submissions, and licensing compliance.

    Key Responsibilities

    + Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.

    + Prepare, compile, and organize documents for international submissions, including drafting reports, and preparing documentation for submissions to support registration or licensing products outside the U.S.

    + Regulatory support to IVDR team.

    + Coordination with international regulatory associate colleagues to obtain product approvals and renewals, including processing apostilled documentation.

    + Organize, update, and maintain regulatory documentation in accordance with department and company procedures including maintaining logs and trackers.

    + Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.

    + Interacts with other cross functional departments to ensure proper coordination of information to meet regulatory requirements.

    + Acts as a core member on development teams to provide regulatory guidance and develop regulatory strategies and timelines.

    + Maintains positive and cooperative communications and collaboration with colleagues.

    Minimum Requirements/Qualifications

    + Minimum of a Bachelor’s degree is required; majors in Science or Engineering are preferred.

    + Minimum of 4 years experience working in medical device regulated industry.

    + Experience and excellent understanding of EU IVD regulation

    + Excellent verbal and written communication skills, and attention to detail.

    + Multitasks, prioritizes and meets deadlines in timely manner.

    + Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously

    + Proficient in MS applications (Excel, Word, Outlook), as well as Document Control such as Oracle and Master Control.

    + Must be able to write clear, understandable technical documentation

     

    Compensation and Benefits

     

    The salary range estimated for this position based in California is $90,900.00–$136,350.00.

     

    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.