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Remote Fda Jobs in Freehold, NJ (NOW HIRING)

Apothékary

PR Consultant

New York, NY · Remote

$3.0K/mo

Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...

Apothékary

PR Consultant

New York, NY · On-site +1

$3.0K/mo

Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...

Apothekary

PR Consultant

New York, NY · On-site +1

$3.0K/mo

Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...

micro1 AI

Director of Biostatistics

New York, NY · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Biostatistician

New York, NY · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Regulatory Affairs Specialist

New York, NY · Remote

$50 - $80/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 ...

micro1 AI

Compliance Officers

New York, NY · Remote

$50 - $80/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 ...

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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 are popular job titles related to Remote Fda jobs in Freehold, NJ?

For Remote Fda jobs in Freehold, NJ, the most frequently searched job titles are:

What cities near Freehold, NJ are hiring for Remote Fda jobs?

Cities near Freehold, NJ with the most Remote Fda job openings:

Remote Fda jobs near you

Regulatory Affairs Contractor - Remote / Telecommute

CYNET SYSTEMS

New York, NY • Remote

$100/hr

Contractor

Re-posted 10 days ago

Job description

Job Overview:

Requirement/Must Have:

  • Bachelor’s degree in engineering, life sciences, regulatory affairs, legal or a related field.
  • 5-10 years+ of global medical device regulatory experience.
  • Proven experience preparing, writing and submitting FDA 510k submissions (end to end).
  • Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity.
  • Strong working knowledge of FDA regulations (21 Parts 807, 820).
  • Strong working knowledge of FDA guidance documents and eStar requirements.
  • Experience with Canadian regulations, EU MDR (2017/745) including Class IIa, Tech docs Annex II/III.
  • Demonstrated ability to work independently as a contractor in a fast-paced environment.

Responsibilities:

  • Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance.
  • Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents).
  • Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format.
  • Lead submission lifecycle activities, including Acceptance Review support (RTA readiness), Substantive Review coordination, drafting and submission of responses to FDA requests for Additional Information, and Interactive review communications.
  • Update submission content and modules as required.
  • Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
  • Provide regulatory leadership through FDA clearance.
  • Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
  • Perform critical review and gap analysis of EU MDR technical file.
  • Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance.
  • Lead or support submission to obtain CE Mark.
  • Perform regulatory strategy and classification confirmation, including Medical Device License (MDL) pathway and Summary of Safety and Effectiveness (SSOR) readiness assessment.
  • Author and compile complete Canadian submission dossiers in accordance with Health Canada structure and requirements.
  • Support review process, including preparation, and coordination of responses to Health Canada information requests.
  • Develop and maintain a harmonized global regulatory dossier to enable efficient market expansion.
  • Define and implement documentation reuse strategies across justification, including identification of gaps, risks, assumptions, and sequencing.
  • Author a comprehensive global strategy document outlining pathways, timelines, and key risks.
  • Provide ongoing regulatory guidance and advisory support to the Business cross-functional teams to ensure compliance and execution alignment.
  • Lead or support global regulatory submissions as needed.

Nice to Have:

  • Experience filing medical device submissions in China and other countries.
  • Experience with audiology devices.
  • Experience with artificial-intelligence enabled devices.

Skills:

  • Strong technical writing and documentation skills.
  • Ability to translate complex technical information into regulatory submissions.
  • Detail-oriented with strong organization skills.
  • Effective communicator across technical and non-technical stakeholders.
  • Ability to manage multiple deliverables and timelines.

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading staffing and recruiting powerhouse. Proudly recognized as a nationally and locally certified diversity firm, Cynet delivers agile, scalable talent solutions across industries. With an active footprint in all 50 U.S. states and Canada, we support thousands of consultants through our expansive, high-performing recruitment engine operating across North America and Asia—ensuring speed, quality, and consistency in every hire.
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About Cynet Systems

Sourced by ZipRecruiter

Cynet Systems Inc is a staffing and recruiting corporation nestled in Ashburn, VA, USA. Established in 2010, the company operates within the Information Technology and Services sector, specializing in providing effective workforce solutions to different business needs, including IT consulting, direct hire, and contract staffing services. Through the years, Cynet Systems has built an impressive portfolio, going beyond borders and expanding its operations internationally in Canada and India. Rooted in its core values of teamwork, leadership, and commitment, Cynet Systems helps businesses unlock their full potential by providing versatile and competent professionals that perfectly align with their needs. Fueled by their unwavering mission to deliver top-tier talent to businesses worldwide, Cynet Systems garnered various recognitions including SIA's fastest-growing staffing firms and Best Place to Work in Virginia for 2019.

Industry

It services

Company size

501 - 1,000 Employees

Headquarters location

Sterling, VA, US

Year founded

2010

Social media

Twitter

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