Senior Regulatory Specialist Job at BioTalent, Union City, CA

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  • BioTalent
  • Union City, CA

Job Description

Sr. Regulatory Affairs Specialist – Medical Device - Onsite Required

Location: East San Francisco Bay Area

Compensation: $100,000–$120,000 base + bonus

A Class I medical device manufacturer is seeking a Senior Regulatory Affairs Specialist to support U.S. and international regulatory submissions and ensure ongoing compliance with global regulations. This is a high-impact role focused on supporting wireless, cybersecurity-enabled, and sterile products.

Key Responsibilities:

  • Prepare, review, and submit regulatory documents including technical files, amendments, supplements, and annual reports for global markets.
  • Maintain regulatory databases and product licenses across various jurisdictions.
  • Interpret and apply FDA (21 CFR Part 820), ISO, and other international medical device regulations.
  • Develop and implement internal regulatory policies and SOPs to support compliance.
  • Collaborate cross-functionally to manage documentation and support audits or regulatory requests.
  • Track submission timelines and ensure timely responses to regulatory agencies.

Required Qualifications:

  • Bachelor’s degree in engineering, life sciences, or a related field.
  • 8–10 years of regulatory affairs experience, including at least 2 years in medical devices.
  • Must have hands-on experience with international product registrations and regulatory strategies.
  • Deep knowledge in one or more of the following areas is required :
  • ▪ Wireless technology
  • ▪ Cybersecurity regulations
  • ▪ Sterilized product requirements
  • Strong written and verbal communication skills.
  • Ability to manage multiple projects and work independently in a fast-paced environment.

This role is best suited for a senior-level regulatory professional who thrives in a dynamic, cross-functional team and has a proven track record navigating complex global regulatory landscapes.

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