Regulatory Affairs Specialist Ii

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, ensuring our food is safe, or helping find cures for cancer.

A Day in the Life:

• Request and track document legalization, apostille and requests for certificates from regulatory agencies.
• Track and maintain files on annual licenses, registrations and listings, including providing information entry into regulatory databases.
• Perform other related duties and responsibilities, on occasion, as assigned.
• Support the preparation of dossiers and submission packages for regulatory agencies, such as IVDR Technical Dossiers for CE Mark approval.
• Assists in the development of regulatory procedures and SOPs
• Communicate information to external customers and other miscellaneous activities as directed.
• Assist in the preparation of regulatory submissions to achieve departmental and organizational objectives including:
  • Review protocols and reports to support regulatory submissions.
  • Organize and assist in the review of materials for inclusion in regulatory submissions.
  • Support the preparation of dossiers and submission packages for regulatory agencies, such as IVDR Technical Dossiers for CE Mark approval.
• Develop regulatory expertise and apply company policies and procedures to resolve routine matters. Comply with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Review protocols and reports to support regulatory submissions.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Organize and assist in the review of materials for inclusion in regulatory submissions.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
• Assist in the review of change assessments to ensure compliance, including working with overseas affiliates on re-registration activities.

Keys to Success:

• Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Excellent communication skills and attention to detail.
• Bachelor’s degree is required with a preference for majors in Science or Engineering required and 1+ years of related experience, preferably with hands-on experience in a medical device-regulated environment/industry (a combination of education or experience can be considered).
• Must be self-motivated, adaptable and have a positive attitude.
• Ability to leverage and/or engage others to accomplish projects.
• Proficient in MS applications (Excel, Word, Outlook).
• Multitasks, prioritizes and meets deadlines in a timely manner.
• Must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations. Excellent oral presentation skills.
• Ability to follow written and verbal directions with a high level of accuracy.
• Strong verbal communication with ability to effectively communicate at multiple levels in the organization.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Compensation and Benefits

The salary range estimated for this position based in California is $72,000.00-$108,000.00.

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:

• 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
• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards