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Remote Fda Compliance Jobs in Rochester, MN (NOW HIRING)

micro1 AI

Compliance Officers

Rochester, MN · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

All JobsFda Compliance JobsRemote Fda Compliance JobsRemote Fda Compliance Jobs in Rochester, MN

Remote Fda Compliance information

See Rochester, MN salary details

$50.8K

$160.1K

How much do remote fda compliance jobs pay per year?

As of Aug 17, 2026, the average yearly pay for remote fda compliance in Rochester, MN is $154,543.00, according to ZipRecruiter salary data. Most workers in this role earn between $159,600.00 and $159,600.00 per year, depending on experience, location, and employer.

What is a remote FDA Compliance specialist?

A Remote FDA Compliance specialist is a professional who ensures that a company’s products, processes, and documentation meet the regulatory requirements set by the U.S. Food and Drug Administration (FDA), all while working remotely. They monitor compliance with FDA regulations, prepare for audits, and help implement necessary changes to maintain certification. These specialists may work for pharmaceutical, biotechnology, medical device, or food companies, providing guidance and documentation support from a remote location. Their expertise helps companies avoid costly compliance issues and maintain the ability to legally market their products in the United States.

What are the key skills and qualifications needed to thrive as a remote FDA Compliance specialist?

To thrive as a Remote FDA Compliance Specialist, you need a deep understanding of FDA regulations, quality systems, and industry standards, often supported by a degree in life sciences or a related field. Familiarity with compliance management software, documentation tools, and sometimes certifications like RAC (Regulatory Affairs Certification) is typically required. Attention to detail, strong organizational skills, and effective communication are critical soft skills for success in this role. These abilities ensure regulatory adherence, minimize compliance risks, and maintain the integrity of remote operations in regulated industries.

How does working remotely as an FDA Compliance specialist affect communication and collaboration with cross-functional teams?

As a remote FDA Compliance specialist, effective communication is crucial since you'll frequently collaborate with departments like quality assurance, regulatory affairs, and manufacturing. Most teams use video conferencing, project management tools, and shared documentation platforms to stay connected and ensure regulatory requirements are met. Being proactive in scheduling regular check-ins and maintaining clear documentation helps prevent misunderstandings and keeps projects on track. While remote work offers flexibility, it also requires strong organizational skills and the ability to communicate complex compliance issues clearly across virtual channels.

What is the difference between Remote Fda Compliance vs Remote Quality Assurance Specialist?

AspectRemote Fda ComplianceRemote Quality Assurance Specialist
CertificationsFDA regulations, GMP, ISOISO, GMP, Six Sigma
Work EnvironmentRegulatory departments, compliance teamsQuality departments, manufacturing sites
Industry UsagePharmaceuticals, biotech, medical devicesManufacturing, pharmaceuticals, biotech

Remote Fda Compliance focuses on ensuring products meet FDA regulations and standards, primarily working with regulatory documentation and audits. Remote Quality Assurance Specialists concentrate on maintaining product quality through process audits and standards compliance. While both roles require knowledge of GMP and ISO, Fda Compliance emphasizes regulatory adherence, whereas Quality Assurance centers on product quality assurance processes.

What are popular job titles related to Remote Fda Compliance jobs in Rochester, MN?

For Remote Fda Compliance jobs in Rochester, MN, the most frequently searched job titles are:

What job categories do people searching Remote Fda Compliance jobs in Rochester, MN look for?

The top searched job categories for Remote Fda Compliance jobs in Rochester, MN are:

What cities near Rochester, MN are hiring for Remote Fda Compliance jobs?

Cities near Rochester, MN with the most Remote Fda Compliance job openings:

Remote Fda Compliance jobs near you
Infographic showing various Remote Fda Compliance job openings in Rochester, MN as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% Remote job distribution, with an average salary of $154,543 per year, or $74.3 per hour.

Compliance Officers

micro1 AI

Rochester, MN • Remote

$50 - $70/hr

Part-time

Posted 13 days ago

Job description

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).

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