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Remote Fda Jobs in Edison, NJ (NOW HIRING)

The Rockridge Group

FDA Attorney

Pine Brook, NJ · On-site +1

A Mid-Level or more senior FDA Attorney (Counsel-level or higher) is sought for Firm X's Pine Brook, NJ, New York City, or fully remote office. They receive an average of 5 new FDA client inquiries ...

Jobot

Senior FDA Attorney

Pine Brook, NJ · On-site +1

$250K - $400K/yr

The firm maintains a highly active FDA practice and receives an average of approximately five new ... A fully remote arrangement may also be considered for an attorney located in another state. Why ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site +1

$154K - $204K/yr

Depending upon location, this role will be hybrid or remote and will require some travel as ... This role will act as the main point of contact and liaison with the US FDA. This position reports ...

System One

Biostatistician

Jersey City, NJ · Remote

$60 - $65/hr

Jersey City, NJ 07302 (Remote) Schedule: 24 hours/week (Choose: 9:00AM - 5:00PM) Compensation: $60 ... FDA regulations and industry standards. This is a part-time consulting position ideal for a ...

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All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Edison, NJ

Remote Fda information

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.

What are popular job titles related to Remote Fda jobs in Edison, NJ? For Remote Fda jobs in Edison, NJ, the most frequently searched job titles are:
What job categories do people searching Remote Fda jobs in Edison, NJ look for? The top searched job categories for Remote Fda jobs in Edison, NJ are:
What cities near Edison, NJ are hiring for Remote Fda jobs? Cities near Edison, NJ with the most Remote Fda job openings:
Remote Fda jobs near you
Infographic showing various Remote Fda job openings in Edison, NJ as of August 2026, with employment types broken down into 79% Full Time, 15% Part Time, 5% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

FDA Attorney

The Rockridge Group

Pine Brook, NJ • On-site, Remote

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 15 days ago

Job description

TITLE: FDA ATTORNEY POSITIION: DIRECT HIRE Firm X, established in 2000, is a national boutique law firm focused exclusively on Healthcare and Life Sciences. The Firm draws on its experience representing stakeholders across the entire healthcare spectrum. In the Life Sciences, Firm X, has represented pharmacies of all kinds and assisted with regulatory, transactional, and litigation matters. On the Healthcare side, the Firm's clients have included large physician group practices, hospitals, hospital medical staff, ambulatory surgery centers, laboratory companies, as well as the complete panoply of ancillary service providers. Firm X attorneys are licensed in numerous states. The Firm has offices in Pine Brook, New Jersey, and New York City. A Mid-Level or more senior FDA Attorney (Counsel-level or higher) is sought for Firm X’s Pine Brook, NJ, New York City, or fully remote office. They receive an average of 5 new FDA client inquiries per week. Responsibilities will align with the Attorney’s background, which should include: • Compounding rules, regulations and FDA guidance o 503A o 503B o Bulk API suppliers and repackagers o FDA audits/investigations • Drug supply chain security and track and trace o Trading partner requirements o Unique trading partners (i.e., 3PLs, brokers, etc.) o Serialization implementation requirements o Other drug supply chain considerations • Drug and device manufacturing rules o CGMP compliance o NDA and ANDA filings and evaluation o 510K Premarket Approval Filings and evaluation o OTC filings and evaluation o Advice on manufacturing practices • Clinical trial rules o Structuring and drafting clinical trial agreements, informed consent forms, master service agreements, and related research contracts o Institutional Review Board (IRB) submissions and compliance o Clinical trial design, study initiation, data use, adverse event reporting, and post-trial obligations • Labeling and advertising reviews • FDA registration and annual filings • FDA inspections, 483 responses and warning letters • Drug withdrawals and recalls • FDA importation and exportation rules • Veterinary medicine and veterinary compounding • Dietary supplements • FDA regulated medical devices • Reviews of clinical literature and incorporation into arguments/strategies (access to these clinical literature directories is a plus) Requirements: • 10+ years FDA experience – private law firm experience strongly preferred, but will also consider in-house candidates • Clinical trial experience a plus • Filing copyrights a plus • Filing patents a plus • May work in the Pine Brook or New York City office; will also consider fully remote arrangement if located in other states • Admitted to practice in at least one US state • Experience performing most/all of the job responsibilities of the position (outlined above) • Team-player mindset, and ability to work cohesively and collaboratively with a team of attorneys • Strong work ethic Benefits: Firm X offers a hybrid schedule, competitive salary, and a full range of benefits, including PTO, medical, dental, vision, 401(k) (upon eligibility to participate), on-site gym (Pine Brook), and opportunities for substantial salary progression based on performance and contributions. *The posted salary will depend on years of experience and other factors.