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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