Job Description - Sr. Regulatory Affairs Specialist: in San Roman
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Sr. Regulatory Affairs Specialist:

Ref: US_EN_6_916327_1477979

Posted 6 days ago

Sr. Regulatory Affairs Specialist:

Direct Hire

The Sr. Regulatory Affairs Specialist provides support for the regulatory department to ensure efficient and compliant business processes and environment. This individual will partner across business functions assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for product registrations.

Essential Functions & Accountabilities of the Sr. Regulatory Affairs Specialist:

  • Leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems.
  • Review and approve device labeling and marketing materials for compliance with applicable regulations.
  • Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
  • Authors regulatory documents under minimal supervision and serves as in-house regulatory expert to internal and external stakeholders.
  • Develop the regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities under minimal supervision.
  • Acts as regulatory liaisons and single point of contact in meetings and interact with members of the project team for assigned projects.
  • Keep abreast of new or revised regulations, guidelines, points to consider, etc.
  • Follows regulatory plans and interfaces with project team members, both within the organization and with a diverse range of external groups to drive corporate initiatives to completion.
  • Qualifications of the Sr. Regulatory Affairs Specialist:

    Knowledge, Skills and Abilities:

  • Excellent oral and written communication skills, with ability to communicate with diverse populations. Able to convey messages in a logical and concise manner.
  • Must be proficient with Microsoft Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulations and graphing).
  • Ability to read and understand highly technical material.
  • Ability to meet deadlines.
  • Strong problem-solving competency.
  • Works schedule hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
  • Complies with all company policies and procedures.
  • Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
  • Conducts self in a professional manner with coworkers, management, customers, and others.
  • Models the corporate values.
  • Work Environment:

  • Professional office environment.
  • Willing to report to work at the San Ramon office.
  • Willing to work in a fast-paced environment.
  • Light lifting of documents, files, and reference books.
  • Experience:

  • 5+ years of experience in an FDA regulated industry required; preferably with medical devices.
  • Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgement.
  • Working knowledge of US regulations and guidance including but not limited to FDA 21 CFR 820, MDSAP, and ISO 13485.
  • Strong initiation and organizational skills.
  • Previous experience working in a geographically diverse business environment.
  • Education:

  • Bachelor’s Degree from a four-year college or university.
  • Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
  • RAPS Certification (RAC) experience is a plus.
  • For more information or to be considered for the Sr. Regulatory Affairs Specialist job please contact Thomas McCarthy at

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