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Remote Regulatory Intelligence Jobs in California

Regulatory Intelligence: Monitor, interpret, and communicate changes in the global regulatory ... Home-based / Remote (USA-based preferred for proximity to North American R&D and commercial ...

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Director, Regulatory Affairs Strategy

San Diego, CA · On-site +1

$159K - $210K/yr

San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Regulatory Intelligence & Compliance * Monitor evolving global regulatory requirements, guidance ...

Manager, Regulatory Affairs

San Francisco, CA · On-site +1

$127K - $165K/yr

... intelligence (AI) Software as a Medical Device (SaMD) products * Key Regulatory SME and review ... Remote - US Actual compensation may vary depending on job-related factors including knowledge ...

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Remote Regulatory Intelligence information

What is the difference between Remote Regulatory Intelligence vs Regulatory Affairs Specialist?

AspectRemote Regulatory IntelligenceRegulatory Affairs Specialist
CredentialsTypically requires degrees in life sciences, certifications in regulatory affairs or intelligenceRequires degrees in life sciences, certifications like RAC or RAPS
Work EnvironmentPrimarily remote, focused on research and analysisOften office-based or hybrid, involved in compliance and submission processes
Industry UsageUsed in pharmaceutical, biotech, and medical device sectors for monitoring regulationsInvolved in preparing and submitting regulatory documents to authorities

Remote Regulatory Intelligence focuses on gathering and analyzing regulatory information remotely, while Regulatory Affairs Specialists handle compliance, submissions, and communication with authorities. Both roles require regulatory knowledge but differ in daily tasks and work settings.

What are the most commonly searched types of Regulatory Intelligence jobs in California?

The most popular types of Regulatory Intelligence jobs in California are:

What are popular job titles related to Remote Regulatory Intelligence jobs in California?

For Remote Regulatory Intelligence jobs in California, the most frequently searched job titles are:

What cities in California are hiring for Remote Regulatory Intelligence jobs?

Cities in California with the most Remote Regulatory Intelligence job openings:

Staff Regulatory Affairs Specialist (Remote)

Stryker

Fremont, CA • On-site, Remote

$124K - $207K/yr

Full-time

Posted 2 days ago

New


Stryker rating

8.2

Company rating: 8.2 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

131st of 494 rated machine equipment manufacturers


Job description

Work Flexibility: Remote

We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular division. This position is based remotely anywhere in the United States.

As theStaff Regulatory Affairs Specialist, you will support Stryker's neurovascular devices. You will work to bring new medical devices to the market while ensuring ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, and interact with regulatory agencies/notified bodies in major markets including the US, EU, Canada, Japan, China, Australia, Brazil, and more.

What you will do

  • Develop and execute regulatory strategies for pre-market products to achieve market access across global regions.
  • Evaluate regulatory requirements and identify submission pathways for new products, ensuring alignment with applicable regulations.
  • Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals.
  • Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
  • Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
  • Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
  • Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
  • Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.

What you need

Required

  • Bachelor's Degree (B.S. or B.A.)

  • Minimum 4 years of experience in an FDA-regulated industry

  • Minimum 2 years of experience in regulatory affairs

  • Demonstrated applied knowledge of FDA and international medical deviceregulations/standards (e.g.EU MDR)

Preferred

  • Bachelor's degree in engineering, science, or related field

  • Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline

  • Experience with Class II or Class III medical devices

  • Experience authoring 510(k) submissions or equivalent regulatory filings

  • Experience interacting with regulatory agencies or supporting regulatory meetings

United States of America Pay Ranges:

  • Puerto Rico: $77,700 - $129,500 USD Annual
  • USN: $95,700 - $159,500 USD Annual
  • US5: $100,500 - $167,500 USD Annual
  • US10: $105,300 - $175,500 USD Annual
  • US15: $110,100 - $183,400 USD Annual
  • US20: $114,800 - $191,400 USD Annual
  • US30: $124,400 - $207,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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