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Temporary Fda Regulatory Jobs (NOW HIRING)

Bizzell

Central North Carolina (Triangle Region) Job Type: Part-Time, Temporary Headquarters: New ... This position plays a critical role in supporting federal and state regulatory enforcement by ...

Bizzell Group

Central North Carolina (Triangle Region) Job Type: Part-Time, Temporary Headquarters: New ... This position plays a critical role in supporting federal and state regulatory enforcement by ...

Actalent

Facilities Engineering Technician

Boulder, CO

$32.64 - $40.34/hr

Follow cGMP and FDA regulatory requirements for all maintenance activities to support a compliant ... If eligible, the benefits available for this temporary role may include the following: • Medical ...

TekWissen LLC

Packaging Operator I

Tampa, FL · On-site

$15 - $20/hr

Temporary Assignment Work Type: Onsite Shift: 07:00 AM to 03:30 PM Summary * Operate and tend ... Working knowledge of cGMP and FDA regulations * Strong attention to detail with accurate and timely ...

Careerxchange

Operations Manager Clinical Trials

Miami, FL · On-site

$41 - $56/hr

Temporary Contract (15 Weeks) Schedule: Monday - Friday | 8:30 AM - 5:00 PM Pay: $41.00 - $56.00 ... Ensure compliance with FDA regulations, Good Clinical Practice (GCP), IRB requirements, and sponsor ...

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How much do temporary fda regulatory jobs pay per hour?

As of Jul 24, 2026, the average hourly pay for temporary fda regulatory in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are some common challenges faced by professionals in a temporary FDA regulatory role?

Professionals in temporary FDA regulatory positions often encounter the challenge of quickly adapting to new organizational processes and understanding the specific regulatory landscape of the company. Since these roles are short-term, there is typically a steep learning curve to become proficient with internal documentation systems, ongoing submissions, and compliance protocols. Additionally, effective communication and collaboration with cross-functional teams, such as R&D, quality assurance, and legal, are essential to ensure timely and accurate regulatory filings. Temporary staff must also stay up-to-date with evolving FDA regulations to minimize compliance risks for the organization.

What are Temporary FDA Regulatory jobs?

Temporary FDA Regulatory jobs involve short-term roles focused on ensuring that products and processes comply with the regulations set by the U.S. Food and Drug Administration (FDA). These positions may include responsibilities like preparing regulatory submissions, assisting with audits, monitoring compliance, and supporting the development of documentation for FDA approval. Temporary roles are often filled to address project-based needs, help with workload spikes, or provide specialized expertise for a limited time. They are common in industries such as pharmaceuticals, medical devices, and food manufacturing where regulatory oversight is critical. Such positions require knowledge of current FDA regulations and strong attention to detail.

What are the key skills and qualifications needed to thrive as a Temporary FDA Regulatory Specialist, and why are they important?

To thrive as a Temporary FDA Regulatory Specialist, you need a solid understanding of FDA regulations, compliance standards, and regulatory submission processes, often supported by a degree in life sciences or a related field. Familiarity with regulatory submission tools (such as eCTD software), document management systems, and potentially certifications like RAC (Regulatory Affairs Certification) is valuable. Attention to detail, strong organizational skills, and clear communication are crucial soft skills for managing documentation and cross-functional collaboration. These competencies ensure timely and accurate regulatory submissions, minimizing compliance risks and supporting successful product approvals.
What cities are hiring for Temporary Fda Regulatory jobs? Cities with the most Temporary Fda Regulatory job openings:
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Temporary Fda Regulatory 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 13 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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