Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

Location/Division Specific Information
Pleasanton, CA

How will you make an impact?

* The Global Regulatory Affairs department in Thermo Fisher Scientifics Life Science Solution group is seeking a Regulatory Affairs professional to join the exciting area of molecular diagnostic products. This position will be located at the Pleasanton, CA facility
* This position will primarily support the Pleasanton site in respect to regulatory input in relation to manufacturing, regulatory compliance/post market matters and CE IVD tech file creation and updates. This support will assist the company in achieving its business goals and pursuing opportunities while ensuring compliance with various government regulation.
* In addition to site manufacturing support, this position will provide support to the Genetic Sciences and Clinical Sequencing divisions by performing additional regulatory activities including regulatory assessment of product changes, Labeling/Advertising/Promotional materials review, submission support, gathering submission documents, assist in drafting submission narratives and reviewing submissions prior to filing. These filings include CE IVD tech files and updates.
* If time allows they may also include 510(k)s, PMA supplements, or traditional PMAs.

What will you do?

* Responsible for providing regulatory compliance support for both regulated and non-regulated IVD products to the Pleasanton, CA facility
* Participate in the review of complaints and assessment of their impact
* Interact with Global Manager of Post Market Compliance by communicating any product concerns and by performing timely reviews ensuring reporting requirements are met.
* Perform regulatory assessment of new and on market product changes
* Review labeling / marketing materials for both regulated and regulated products against internal policies and external guidance /regulations
* Create and update CE IVD technical files.
* Prepare and maintain state and federal medical device licensing, establishment registration and listings
* Prepare draft HHEs, product field action and MDR reports
* Obtain regulatory permits, including compliance with import / export clearance requirements and regulations.
* Participate in project teams (existing products and new product introductions)
* Will have direct line reporting to Manager of Regulatory Affairs.
* Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, and inspection reports,
* Over time may conduct trainings and/or communicate appropriate materials, as needed, in order to enhance teams knowledge of working in a regulated environment.
* Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
* Participate in audits, both physical and paper, to ensure compliance with various regulations.

How will you get here?

* A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.

Experience:

* Must have a minimum of 3 years Regulatory Affairs experience within the medical device or IVD industry.
* Have an understanding of 21cfr part 803 and 806.
* Have an understanding of design control, cGMP/Quality Systems, labeling requirements, risk management, design and process verification and validation.
* Experience in the balance and application of regulatory requirements
* Capacity to communicate regulations to technical functions within the company
* Location: role is based in Pleasanton, CA
* This position has not been approved for Relocation Assistance.

Required Qualifications:

* High energy level; positive attitude; works well under stress; strong communicator
* Hands-on, action-oriented, and able to implement effectively through his/her team
* Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
* Able to work autonomously in a matrix-managed organization
* Ability to provide solutions based on knowledge of regulation and industry experience
* Comfortable with ambiguity and change

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Apply today! 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.