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Regulatory Affairs Associate Jobs in Boca Raton, FL

Open Scientific

Regulatory Manager

Sunrise, FL

... associates and affiliates. Review and provide regulatory authorization for Nonconformance reports (NCR) Provide Regulatory Affairs support during internal and external audits. Prepare and file ...

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How much do regulatory affairs associate jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for regulatory affairs associate in Boca Raton, FL is $37.44, according to ZipRecruiter salary data. Most workers in this role earn between $30.00 and $44.33 per hour, depending on experience, location, and employer.

What is a regulatory affairs associate?

A regulatory affairs associate helps medical and pharmaceutical companies navigate regulatory approval processes so that products conform to all local, state, and federal regulations. As a regulatory affairs associate, you work with a team to obtain approval for products, maintain database systems for relevant information, and create reports required by federal or government agencies. You stay abreast of developments in legislation and regulation that may affect your company, and advise others on best practices for product development within a regulated framework.

What are some common challenges regulatory affairs associates face when coordinating with cross-functional teams?

Regulatory Affairs Associates often collaborate closely with departments such as research and development, quality assurance, and marketing. A common challenge is ensuring all stakeholders understand and adhere to regulatory requirements, which may change frequently. Balancing project timelines with the need for accurate and compliant documentation can also be demanding, especially when teams have competing priorities. Effective communication and proactive planning are key to navigating these challenges successfully.

What are the key skills and qualifications needed to thrive as a regulatory affairs associate, and why are they important?

To thrive as a Regulatory Affairs Associate, you need a solid background in life sciences or related fields, attention to detail, and knowledge of regulatory guidelines and standards. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong organizational skills, effective communication, and the ability to work collaboratively are important soft skills in this role. These abilities ensure accurate documentation, timely regulatory submissions, and successful navigation of complex compliance requirements.
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Regulatory Affairs Associate jobs near you
Infographic showing various Regulatory Affairs Associate job openings in Boca Raton, FL as of August 2026, with employment types broken down into 1% As Needed, 69% Full Time, 28% Part Time, 1% Temporary, and 1% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $77,871 per year, or $37.4 per hour.

Regulatory Affairs Manager

Open Scientific

Plantation, FL • On-site

Full-time

Re-posted 5 days ago

Job description

Company Description
Headquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide.
This is a great step for someone who has progressed to a Manager level and wants to progress into a Director role in the future. If you are looking to take on a challenging role within a rapidly growing division that provides an A+ environment and excellent benefits, do not miss out on a potential opportunity to get your foot in the door.
Job Description
-Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)
-Develop Design Dossiers and Technical Files for CE marking purposes
-Develop other international regulatory submissions as required
-Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
-Review, edit and provide regulatory and quality system approval for project documentation.
-Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.
-Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
-Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.
-Develop procedures to ensure regulatory compliance
-Act as an active regulatory representative on project teams
-Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
-Review and provide regulatory authorization for Nonconformance reports (NCR)
-Provide Regulatory Affairs support during internal and external audits.
-Prepare and file facility registration documents
-Conduct external audit activities as requested
-Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA
-Manage commercial device tracking
-Develop clinical protocols and clinical study reports
-Prepare and submit medical device reports
-Perform various other duties as assigned
Qualifications
-Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).
-Solid knowledge of US and European regulatory processes, including Class III is required.
-Practical (hands-on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.
-Experience interacting with U.S. FDA and European Notified Bodies is required.
-Experience presenting at FDA meetings is preferred.
-Sound knowledge and understanding of how IDE-regulated clinical studies are performed is required.
-Experience in review and approval of promotional review process strongly preferred
-Comprehensive Knowledge of Design Control processes and controls
-Comprehensive Knowledge of Regulatory Standards needed in the medical device environment.
Please send suitable resumes in confidence to JPCuadra @ openscientific.com
Additional Information
All your information will be kept confidential according to EEO guidelines.

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