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Medical Device Manufacturing Jobs in Boca Raton, FL

Open Scientific

Regulatory Manager

Sunrise, FL

... manufacturing sectors. Position Summary Manages the regulatory side of the company business to ... Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre ...

iMPact Business Group

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3D Image Technician - 27530

Weston, FL · On-site

$20/hr

  • Medical

  • Dental

  • Vision

Our client, a Global Medical Device Manufacturer, has an immediate opening for a 3D Image Surgery Technician for a 12-month+ contract-to-hire opportunity . * Training is provided; medical experience ...

Terumo Corporation

Manufacturing Group Leader

Sunrise, FL · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... to produce medical device products. Associates are required to wear special garments while working in the controlled environment area (CEA). Group Leader is expected to have (or to obtain ...

Terumo Corporation

Manufacturing Group Leader

Sunrise, FL · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... to produce medical device products. Associates are required to wear special garments while working in the controlled environment area (CEA). Group Leader is expected to have (or to obtain ...

Terumo Corporation

Manufacturing Group Leader

Sunrise, FL

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... to produce medical device products. Associates are required to wear special garments while working in the controlled environment area (CEA). Group Leader is expected to have (or to obtain ...

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All JobsMedical Device Manufacturing JobsMedical Device Manufacturing Jobs in Boca Raton, FL

Medical Device Manufacturing information

See Boca Raton, FL salary details

$17

$25

$38

How much do medical device manufacturing jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for medical device manufacturing in Boca Raton, FL is $25.74, according to ZipRecruiter salary data. Most workers in this role earn between $21.92 and $30.10 per hour, depending on experience, location, and employer.

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

To thrive in Medical Device Manufacturing, you need strong attention to detail, knowledge of quality assurance processes, and an understanding of regulatory standards such as ISO 13485 or FDA requirements. Experience with manufacturing equipment, ERP systems, and specialized tools for assembly and testing is typically required, and certification in areas like Six Sigma or Lean Manufacturing can be advantageous. Effective communication, teamwork, and problem-solving skills help individuals excel in fast-paced, multidisciplinary environments. These skills are vital for maintaining product safety, ensuring regulatory compliance, and meeting production targets in the highly regulated medical device industry.

Is medical device manufacturing a good job?

Medical device manufacturing is considered a stable and growing field with opportunities for skilled workers, including roles in assembly, quality control, and engineering. It often requires attention to detail, technical skills, and adherence to safety and regulatory standards, with potential for career advancement and competitive wages.

What career advancement opportunities are available in medical device manufacturing?

Medical Device Manufacturing offers a variety of career advancement paths, allowing employees to move into roles such as production supervisor, quality assurance specialist, or process engineer as they gain experience. Many companies provide on-the-job training, mentorship programs, and support for additional certifications to help employees further develop their technical and leadership skills. Team members who demonstrate strong performance and a commitment to continuous improvement may also transition into management positions or cross-functional roles in research and development, regulatory affairs, or supply chain management. This field values both specialized technical expertise and a proactive approach to professional growth, providing long-term career stability and diverse opportunities.

What is a medical device manufacturing job?

A Medical Device Manufacturing job involves producing, assembling, and testing medical devices to ensure they meet regulatory and quality standards. Workers in this field may operate machinery, inspect products, and follow strict guidelines to maintain safety and efficiency. Roles can range from machine operators and quality control inspectors to engineers and regulatory compliance specialists. This industry is essential for creating devices like surgical instruments, pacemakers, and diagnostic equipment used in healthcare. Attention to detail, adherence to regulations, and technical skills are key for success in this field.

What are popular job titles related to Medical Device Manufacturing jobs in Boca Raton, FL? For Medical Device Manufacturing jobs in Boca Raton, FL, the most frequently searched job titles are:
What job categories do people searching Medical Device Manufacturing jobs in Boca Raton, FL look for? The top searched job categories for Medical Device Manufacturing jobs in Boca Raton, FL are:
What cities near Boca Raton, FL are hiring for Medical Device Manufacturing jobs? Cities near Boca Raton, FL with the most Medical Device Manufacturing job openings:
Medical Device Manufacturing jobs near you
Infographic showing various Medical Device Manufacturing job openings in Boca Raton, FL as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, 11% Contract, and 6% Nights. Highlights an 89% In-person, and 11% Remote job distribution, with an average salary of $53,533 per year, or $25.7 per hour.

Regulatory Affairs Manager

Open Scientific

Plantation, FL • On-site

Full-time

Re-posted yesterday

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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