Regulatory Affairs Specialist / Senior Specialist

Job Description

The Regulatory Affairs Specialist/Senior Specialist is responsible for the support of a variety of regulatory affairs activities and projects with oversight from senior regulatory staff. This includes tasks and deliverables such as US and international product submissions, registration life cycle maintenance, registration file organization and related activities.

• Responsible for generating and delivering documentation for life cycle management and/or registration of products domestically and internationally
• Coordinates assessment of product changes to capture any impact to existing or in-process product registrations and letters to file
• Coordinates and documents regulatory risk determinations for clinical studies
• Assists in submission activities for a variety of device regulatory approvals including the pre-submissions, premarket approvals (PMAs), CE mark, IDE submission, Annual Reports, Export certificates, etc.
• Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
• Work with senior regulatory staff to identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plan
• Assists in implementing department procedures and maintaining regulatory requirement matrices

Qualifications

• Bachelor’s degree in a science, engineering, public health, or a related field
• At least 2 years of experience in a regulatory affairs role in the medical device or diagnostic industry
• General knowledge of regulatory issues and challenges associated with medical device development
• RAC Certification preferred
• Knowledgeable in the aspects of regulatory strategy creation, design control, and cGMP / Quality Systems
• Experience providing RA feedback to cross-functional project teams providing active and successful regulatory guidance and RA strategies
• Understanding of molecular technologies and the impact on outcomes and diagnostic results.
• Ability to work effectively in a fast-paced environment
• Ability to work independently as well as within a team
• Strong organizational skills and attention to detail
• Excellent oral and written communication skills
• Strong project management abilities
• Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency

Additional Information

Employee may be required to lift routine office supplies up to 20 lbs and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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