Opening For Sr. Regulatory Analyst : San Francisco

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Amar Annamalai
Amar Annamalai's picture
Opening For Sr. Regulatory Analyst : San Francisco

 The Genetic Systems Division of Thermo Fisher Scientific is seeking an experienced Senior Regulatory Analyst. The successful candidate will be responsible for providing Regulatory Affairs support to the Genetic Systems research teams and their external contract services partners. This position will provide strategic and tactical support to the Product Development team and the Contract Services business located in South San Francisco and will report to the Senior Director of the Genetic Systems Custom Solutions Business with dotted line reporting to the Director of Global Regulatory Affairs. This position is responsible for defining and executing the regulatory strategies and subsequent submissions to support key product development programs and third party contract services programs. In addition, they will ensure adherence to established processes, policies and procedures of the company and external regulatory agencies. 
 
RESPONSIBILITIES:
Responsible for defining and executing regulatory strategy, providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
Writes, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including International Authorities, including Pre-submission documents, PMA and /or 510k submissions, CE/IVD Technical Files.
Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, address questions etc.
Services as RA subject matter expert and keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news
Coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.;
Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Participate in business meetings with existing and prospective external partners
 
Minimum Qualifications (must have)
EXPERIENCE / EDUCATION:
Minimum of 5 years of IVD Regulatory Affairs experience. This experience must include either 510(k) and/or PMA Submissions. CE-IVD experience is desirable.
Demonstrated experience in multiple aspects of regulatory affairs, including; strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
Experience representing RA on project core teams providing active and successful regulatory guidance and RA strategy.
Successful experience in communicating with Regulatory Agencies.
Customer facing experience.
Minimum requirement of a Bachelor’s degree in life sciences, bio-engineering or related science. SKILLS AND QUALIFICATION
Positive attitude and service-minded approach.
Excellent written and verbal communication skills, including presentation skills. Demonstrated ability to communicate clearly, succinctly, and effectively in person, over the phone, and in writing. Comfortable communicating with executive management.
Strong interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
Ability to work as a member of a team in a timeline-driven environment with limited supervision.
Must possess strong organizational skills Detail-oriented, yet able to handle multiple projects concurrently.
 
Preferred Qualifications (nice to have)
RAC certification from RAPS or other recognized institute is preferred.
 
EOE 
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