ZipRecruiter

Log In

2

Remote Fda Jobs in California, MD (NOW HIRING)

All JobsFda JobsRemote Fda JobsRemote Fda Jobs in California, MD

Remote Fda information

What is a remote FDA?

A Remote FDA job typically involves working for or with the U.S. Food and Drug Administration (FDA) from a remote location. These roles can include regulatory affairs, compliance, medical writing, research, and reviewing submissions for drug and medical device approvals. Remote FDA jobs require knowledge of FDA regulations, strong analytical skills, and experience in healthcare, pharmaceuticals, or related fields. They offer flexibility while maintaining high regulatory standards and ensuring public health and safety.

What are the typical daily responsibilities of a remote FDA compliance specialist?

A Remote FDA Compliance Specialist generally reviews and updates regulatory documents, conducts virtual audits, and monitors company practices for FDA compliance. They regularly collaborate with cross-functional teams, such as quality assurance, legal, and product development, to provide guidance on regulatory requirements and respond to compliance queries. Additionally, they prepare and submit necessary reports, maintain records for inspections, and stay current on evolving regulations. This remote structure allows flexibility but also demands excellent organization, communication, and self-discipline to ensure all deadlines and compliance standards are met.

What are the key skills and qualifications needed to thrive in the remote FDA position, and why are they important?

To excel as a Remote FDA Compliance Specialist, you need in-depth knowledge of FDA regulations, quality assurance procedures, and a background in life sciences or a related field. Proficiency in using compliance management systems, electronic document management tools, and relevant certifications such as RAC (Regulatory Affairs Certification) are often required. Exceptional attention to detail, self-motivation, and strong written and verbal communication skills are vital for remote collaboration and thorough documentation. These abilities ensure regulatory adherence, minimize compliance risks, and facilitate effective remote teamwork within the pharmaceutical or medical device industry.

What jobs can I do completely remotely as a remote FDA?

A remote FDA typically refers to a Food and Drug Administration-related role that can be performed remotely, such as regulatory affairs specialists, quality assurance managers, or compliance analysts. These positions often require knowledge of regulations, strong communication skills, and familiarity with digital tools for document review and reporting, allowing work to be done entirely online. However, some roles may require occasional on-site visits or inspections depending on the specific job and employer policies.

What cities near California, MD are hiring for Remote Fda jobs?

Cities near California, MD with the most Remote Fda job openings:

Remote Fda jobs near you
Infographic showing various Remote Fda job openings in California, MD as of August 2026, with employment types broken down into 55% Full Time, and 45% Part Time. Highlights an 100% Remote job distribution.

Senior Staff Software Advance Quality Engineer

Stryker

California, MD • On-site, Remote

Full-time

Posted 28 days ago

Stryker rating

8.2

Company rating: 8.2 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

129th of 495 rated machine equipment manufacturers

Job description

Work Flexibility: Remote or Hybrid or OnsiteIt's Time to Join Stryker!Why Join Us

In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery.

Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Platform Hub. In this role, you will partner with software R&D teams to establish, implement, and improve quality processes across digital, connected, SaaS, and cloud-based products.

You will provide quality-system guidance throughout the software development lifecycle, support audit and compliance readiness, and translate regulatory and industry requirements into practical, scalable processes. You will collaborate with R&D, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality to enable efficient and compliant software delivery.

This is not a software testing or test-execution role. This position focuses on software quality systems, SDLC governance, risk management, audit readiness, and process improvement.

What You Will DoSoftware Quality Systems and Process Leadership
  • Serve as a software quality and compliance subject matter expert for software, SaaS, cloud-hosted, and connected products.
  • Guide software R&D teams through applicable Quality Management System processes, procedures, and documentation requirements.
  • Develop, maintain, and improve software quality procedures, work instructions, templates, and guidance documents.
  • Identify process gaps and lead continuous-improvement initiatives across the software development lifecycle.
  • Translate regulatory, quality, security, and compliance requirements into practical development processes.
  • Establish scalable quality practices that support compliant and efficient software delivery.
  • Assess emerging regulations and standards and determine their impact on software-development processes.
Software Lifecycle and Risk Management
  • Provide quality guidance throughout requirements, design, development, change control, release, maintenance, and retirement activities.
  • Participate in design reviews, risk assessments, change assessments, and release-readiness reviews.
  • Ensure software quality and compliance risks are identified, evaluated, documented, and appropriately addressed.
  • Integrate quality and risk-management practices into Agile, DevOps, and CI/CD environments.
  • Review software quality deliverables and provide clear, risk-based guidance to project teams.
Audit and Compliance Readiness
  • Support readiness activities for SOC 2, ISO 27001, HIPAA, FDA, and other applicable frameworks.
  • Partner with control owners to ensure controls are implemented, maintained, and supported by objective evidence.
  • Support internal and external audits through gap assessments, evidence collection, auditor interaction, and remediation.
  • Lead or support investigations, root-cause analysis, corrective actions, and effectiveness monitoring related to software quality issues.
Cross-Functional Leadership
  • Partner with Software Engineering, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality teams.
  • Mentor and coach teams on quality-system requirements, software risk management, and compliant development practices.
  • Influence technical and business stakeholders without direct authority.
  • Resolve conflicts between development priorities, delivery timelines, and quality or compliance requirements.
  • Promote the integration of quality, security, compliance, and risk management into software-development decisions.
What You Need
  • Bachelor's degree in Software Engineering, Computer Science, Engineering, Quality, or a related technical discipline is required.
  • Six or more years of professional experience in software quality, quality systems, software compliance, audit, or a related field supporting software, SaaS, cloud-based, or connected products is required.
  • Experience developing, implementing, maintaining, or improving software quality processes or procedures is required.
Preferred Qualifications (You Do Not Need to Have All of These)
  • Master's degree or another advanced technical degree.
  • Professional experience in software engineering or development before transitioning into software quality, compliance, or quality systems.
  • Strong understanding of the software development lifecycle, including change control, risk management, audit readiness, and Quality Management System processes.
  • Experience partnering with software development or R&D teams to implement or improve software quality processes.
  • Experience supporting regulated software products, preferably within medical devices, digital health, healthcare technology, or another compliance-driven industry.
  • Experience with SOC 2, ISO 27001, HIPAA, FDA software expectations, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485, or comparable frameworks.
  • Working knowledge of cloud platforms, DevOps, CI/CD, and software security controls.
  • Experience leading audits, gap assessments, remediation activities, quality investigations, or corrective and preventive actions.
  • Demonstrated ability to influence cross-functional teams, communicate complex requirements, and lead process improvements without direct authority.
  • Professional certification such as CSQE, CQE, CQA, or an equivalent quality or compliance credential.

United States of America Pay Ranges:

  • Puerto Rico: $102,600 - $171,000 USD Annual
  • USN: $118,000 - $196,700 USD Annual
  • US5: $123,900 - $206,500 USD Annual
  • US10: $129,800 - $216,400 USD Annual
  • US15: $135,700 - $226,200 USD Annual
  • US20: $141,600 - $236,000 USD Annual
  • US30: $153,400 - $255,700 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%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.

What Stryker employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply