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Remote Fda Jobs in Detroit, MI (NOW HIRING)

Career Renew

CAE/FEA Engineer

Detroit, MI · Remote

$170K - $235K/yr

Career Renew is recruiting for one of its clients a CAE/FEA Engineer - this is a fully remote role ... Lead the translation of complex regulatory requirements (FDA, ISO, etc.) into technical constraints ...

A.N. Deringer

Import Specialist II

Dearborn, MI · Remote

$20 - $30/hr

This is a remote role that follows a Tuesday through Sunday, 4:00PM to 12:00AM Eastern Standard ... Government regulatory agencies such as FDA, EPA, USFWS, etc. * Maintains communication with ...

A.N. Deringer, Inc.

Import Specialist II

Dearborn, MI · Remote

$20 - $30/hr

This is a remote role that follows a Tuesday through Sunday, 4:00PM to 12:00AM Eastern Standard ... Government regulatory agencies such as FDA, EPA, USFWS, etc. * Maintains communication with ...

FedEx Logistics

Sr Regulatory Advisor

Romulus, MI · Remote

$4.9K - $9.4K/wk

... FDA registrations, etc. Review quality referral disputes for accuracy as an impartial mediator ... This role is REMOTE **Candidates MUST reside within a 50 mile radius of one of the following ...

A.N. Deringer, Inc.

Import Specialist I

Dearborn, MI · Remote

$19 - $24/hr

This is a remote role supporting a Monday through Friday, 8:00AM to 5:00PM Eastern Standard Time ... Government regulatory agencies such as FDA, EPA, USFWS, etc. * Coordinates shipping details with U.

A.N. Deringer

Import Specialist I

Dearborn, MI · Remote

$19 - $24/hr

This is a remote role supporting a Monday through Friday, 8:00AM to 5:00PM Eastern Standard Time ... Government regulatory agencies such as FDA, EPA, USFWS, etc. * Coordinates shipping details with U.

All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Detroit, MI

Remote Fda information

See Detroit, MI salary details

$25.7K

$87.5K

$172.3K

How much do remote fda jobs pay per year?

As of Aug 6, 2026, the average yearly pay for remote fda in Detroit, MI is $87,534.00, according to ZipRecruiter salary data. Most workers in this role earn between $50,856.00 and $113,562.00 per year, depending on experience, location, and employer.

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 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 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.

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Remote Fda jobs near you

Senior Biostatistician - Remote (US)

MMS Holdings Inc.

Canton, MI • On-site, Remote

Full-time

Re-posted 26 days ago

Job description

About MMS
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Senior Biostatistician:
Responsibilities:
  • Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.
  • Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.
  • Review ADAM and TLFs; work with client and programmers to resolve comments.
  • Strong programming and logic skills (working knowledge of SAS)
  • Ability to apply drug development knowledge during production of high quality statistical analyses.
  • Perform sample size calculations for a variety of scenarios and study designs.
  • Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.
  • Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas.
  • Understand the various tools that we work with
  • High level knowledge of drug development as it pertains to biostatistics.
  • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
  • Review the statistical section of a Sponsor's protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor's protocol with minimal support
  • High proficiency with MS Office applications
  • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation.
  • Provide ICH guideline based input as applicable to statistics.
  • Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.
Requirements:
  • College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.
  • Minimum of 5 years' experience in Biostatistics or similar field required.
  • Expert knowledge of scientific principles and concepts.
  • Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses.
  • Strong SAS programming, SAS base, SAS macro experience.
  • Thorough knowledge and understanding of clinical data preferred.
  • Strong experience with data and production of TLGs.
  • Excellent scientific writing skills.
  • Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • Good communication skills and willingness to work with others to clearly understand needs and solve problems.
  • Excellent problem-solving skills.
  • Good organizational and communication skills.
  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
  • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

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