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Remote Fda Jobs in Hanover, MA (NOW HIRING)

Qualio

Account Executive (Remote)

Boston, MA · Remote

... and FDA requirements. Qualio is ISO 27001, ISO 9001, and ISO 27701 certified, reflecting our ... The Qualio team is all-remote, and currently distributed across North America, Europe and Australia.

Vor Bio

Director, Biostatistics

Boston, MA · On-site +1

Boston, MA preferred open to remote work The Director, Biostatistics serves as a senior individual ... Represent Vor's Biostatistics function, asappropriate, in regulatory agency meetings (FDA Type A/B ...

Vue Health

Digital Designer-Freelance/Hourly

Boston, MA · Remote

$65 - $85/hr

Freelance Digital Designer (Pharmaceutical Advertising) - 100% Remote We're looking for a Freelance ... Ensure all work aligns with FDA/regulatory guidelines and client brand standards * Manage multiple ...

Vue Health

Digital Designer-Freelance/Hourly

Boston, MA · Remote

Freelance Digital Designer (Pharmaceutical Advertising) 100% Remote Were looking for a Freelance ... Ensure all work aligns with FDA/regulatory guidelines and client brand standards * Manage multiple ...

Whoop

Director, Clinical Science

Boston, MA · On-site +1

$86K - $118K/yr

... remote patient monitoring. * Familiarity with machine learning-enabled medical devices, algorithm validation, and software development lifecycles preferred. * Experience interacting with FDA ...

LivaNova

Director - Product Security

Boston, MA · On-site +1

$253K - $265K/yr

... FDA, and is critical to ensuring patient safety, maintaining market access, and protecting the ... Houston, TX is the ideal location for this role, but this is open to Remote opportunities for well ...

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All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Hanover, MA

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 job?

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 cities near Hanover, MA are hiring for Remote Fda jobs? Cities near Hanover, MA with the most Remote Fda job openings:
Remote Fda jobs near you
Temp to Perm - Remote Opportunity - Regulatory Affairs Manager

Temp to Perm - Remote Opportunity - Regulatory Affairs Manager

Collabera

Mansfield, MA • Remote

Other

Posted 18 days ago

Job description

Company Description

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. 


Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.

Job Description

Required: (Remote Opportunity - Temp to Perm)

The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.

In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.

The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.

Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.

Key responsibilities:

Lead Regulatory Associates or Specialists in addition to work as an individual contributor

Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)

Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release. 

Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.

Monitor and provide management with impact of changes in the Regulatory environment.

Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.

Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.

Support Design Control process.

Prepare Rational to file documentation for modifications to devices when appropriate.

Participate in FDA & other notified body Inspections.

Author and/or review regulatory procedures and update as necessary.

Review change control documents and ascertain Regulatory impact for external and internal documents.

Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.

Review promotional material and labeling for regulatory compliance.

Qualifications

Required qualifications:(Remote Opportunity)

Bachelor's degree required. Scientific or engineering field preferred.

5+ years of medical device regulatory affairs experience.

Must have authored 510(k) submissions

Must have knowledge of U.S. FDA regulations and standards

3+ years of experience interacting with FDA and/or other regulatory agencies

Experience with devices containing software is strongly preferred.

Must work well in team environments

Must demonstrate leadership skills in team setting.

Proven analytical abilities

Solid understanding of manufacturing and change control, and an awareness of regulatory trends

Additional Information

To know more on this position or to schedule an interview, please contact;

Ujjwal Mane

973-805-7557

ujjwal.mane[@]collabera.com

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