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Medical Device Operations Jobs in Florida (NOW HIRING)

Open Scientific

Regulatory Manager

Sunrise, FL · On-site

Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre ... Development, Operations, Clinical Research, Quality Assurance or other related departments.

Arthrex

Senior Engineer I - Molding Process

Ave Maria, FL · On-site

$93K - $120K/yr

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their ... Develop a continuous improvement culture, skills sets and tools to enhance quality and operational ...

ARTHREX

Senior Engineer I - Molding Process

Ave Maria, FL

$93K - $120K/yr

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their ... Develop a continuous improvement culture, skills sets and tools to enhance quality and operational ...

ARTHREX

Customer Service Operations Intern

Fort Myers, FL · On-site

$14.25 - $18.75/hr

Customer Service Operations Intern Arthrex is a global medical device company and leader in orthopedics medical education. With a corporate mission of Helping Surgeons Treat Their Patients Better ...

Arthrex

Customer Service Operations Intern

Fort Myers, FL · On-site

$14.25 - $18.75/hr

Customer Service Operations Intern Arthrex is a global medical device company and leader in orthopedics medical education. With a corporate mission of Helping Surgeons Treat Their Patients Better™ ...

Arthrex

Customer Service Operations Intern

Fort Myers, FL · On-site

$14.25 - $18.75/hr

Customer Service Operations Intern Arthrex is a global medical device company and leader in orthopedics medical education. With a corporate mission of Helping Surgeons Treat Their Patients Better™ ...

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Medical Device Operations information

What is the difference between Medical Device Operations vs Medical Device Quality Assurance?

AspectMedical Device OperationsMedical Device Quality Assurance
Primary FocusManaging manufacturing, supply chain, and product deploymentEnsuring product quality, compliance, and safety standards
Required CertificationsRegulatory knowledge, manufacturing certificationsQuality management certifications, ISO standards
Work EnvironmentManufacturing plants, supply chain settingsQuality labs, compliance departments
Industry UsageUsed across production and logistics teamsUsed within quality control and regulatory teams

Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.

What are some common challenges faced by professionals in medical device operations, and how can they be addressed?

Professionals in Medical Device Operations often face challenges related to maintaining strict regulatory compliance, ensuring product quality, and managing cross-functional communication between manufacturing, quality assurance, and regulatory teams. Staying up to date with changing FDA or international regulations is essential, and frequent documentation or process audits can be demanding. Building strong organizational habits, leveraging digital tracking tools, and fostering open communication channels with other departments can help address these challenges and ensure smooth operations.

What is medical device operations?

Medical device operations refer to the processes and activities involved in the manufacturing, assembly, quality control, supply chain management, and distribution of medical devices. This field ensures that devices are produced efficiently, meet regulatory standards, and are delivered safely to healthcare providers and patients. Operations teams collaborate with engineering, quality assurance, and regulatory departments to maintain compliance and optimize production workflows. Their work is crucial for ensuring that medical devices are safe, effective, and readily available for patient care.

What are the key skills and qualifications needed to thrive in medical device operations?

To thrive in Medical Device Operations, you need a solid understanding of regulatory compliance, quality assurance, and supply chain management, often supported by a degree in engineering, life sciences, or business. Familiarity with quality management systems (QMS), FDA regulations, and software like ERP systems is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These competencies are vital for delivering safe, high-quality medical devices efficiently and in accordance with rigorous industry standards.
What are popular job titles related to Medical Device Operations jobs in Florida? For Medical Device Operations jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Medical Device Operations jobs in Florida look for? The top searched job categories for Medical Device Operations jobs in Florida are:
What cities in Florida are hiring for Medical Device Operations jobs? Cities in Florida with the most Medical Device Operations job openings:
Medical Device Operations jobs near you
Infographic showing various Medical Device Operations job openings in Florida as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Regulatory Affairs Manager

Open Scientific

Plantation, FL • On-site

Full-time

Re-posted 27 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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