Thermo Fisher Scientific Regulatory Affairs Specialist II in Fremont, California

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Regulatory Affairs Specialist II will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory assessments, ensuring products and procedures comply with regulatory agency specifications.

What will you do?

  • Assist in the preparation of regulatory submissions to achieve departmental and organizational objectives.

  • Create reviews and approve change order requests.

  • Use risk-based approach for prioritization of activities.

  • In collaboration with senior team member (s), initiate review and evaluation of communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.

  • Review protocols and reports to support regulatory submissions.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.

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

  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Assist with FDA 510(k), Japanese and European submissions.

  • Communicate information to external customers and other miscellaneous activities as directed.

  • Prepare technical files for CE Mark approval.

  • Perform other related duties and responsibilities, on occasion, as assigned.

How will you get here?

  • Bachelor’s degree is required with a preference for majors in Science or Engineering.

  • Minimum of 2-4 years of experience working in a medical device regulated environment/industry are required.

  • Experience with assessment of product labeling preferred.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multitasks, prioritizes and meets deadlines in timely manner.

  • Excellent communication skills and attention to detail.

  • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude.

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

  • Proficient in MS applications (Excel, Word, Outlook).

  • 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.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today http://jobs.thermofisher.com at http://jobs.thermofisher.com/

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.