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Fda Regulatory Jobs in Puerto Rico (NOW HIRING)

Weil Group, Inc

PR · On-site

$15/hr

... and FDA regulations. Key Responsibilities * Operate packaging lines on a daily basis. * Perform routine quality checks to ensure products meet specifications. * Perform routine safety checks to ...

Weil Group, Inc.

Packaging Technician

Guayama, PR · On-site

$15/hr

... and FDA regulations. Key Responsibilities * Operate packaging lines on a daily basis. * Perform routine quality checks to ensure products meet specifications. * Perform routine safety checks to ...

FITS LLC

Maintenance Specialist

Juncos, PR · On-site

$20.25 - $28/hr

Able to read and understand technical data and OEM Equipment Manuals. * cGMP's and FDA regulations. * Maximo. The Personality Part: * Our Next Piece is someone who treats everyone they meet like ...

Pharma Bioserv

Be Seen First

Sr. Quality Assurance Specialist

San Juan, PR · On-site

$60K - $75K/yr

Solid understanding of FDA regulations and applicable state/local requirements. * Proven success delivering results in fast-paced, dynamic, and unstructured environments. * ASQ certification (e.g ...

medplast

Engineering - Senior Process Engineer

Vega Baja, PR · On-site

$88K - $113K/yr

... regulatory, FDA and ISO compliance in all areas of responsibilities. • Able to supervise technical personnel and provide guidance. • Must comply with requirements of ISO 13485 and company ...

medplast

Engineering - Senior Process Engineer

Vega Baja, PR · On-site

$88K - $113K/yr

... regulatory, FDA and ISO compliance in all areas of responsibilities. • Able to supervise technical personnel and provide guidance. • Must comply with requirements of ISO 13485 and company ...

FITS LLC

Packaging Supervisor

Guayama, PR · On-site

Planning, organizing, staffing, performance assessment, and ensuring compliance with corporate policies, SOPs, cGMP, and FDA regulations. The Personality Part: * Our Next Piece is someone who treats ...

Biosimilar Sciences PR LLC

PR · On-site

... regulatory submissions. We are committed to compliance with FDA, EMA, and ICH requirements and to fostering a strong culture of quality, contamination control, and continuous improvement. Job ...

Moriah Engineering

Automation Specialist

Jayuya, PR · On-site

Support validation and qualification activities in compliance with FDA regulations and applicable industry guidelines. * Stay current with industry trends and incorporate best practices into ...

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Fda Regulatory information

What is an FDA Regulatory?

An FDA Regulatory job involves ensuring that products such as pharmaceuticals, medical devices, and biologics comply with U.S. Food and Drug Administration (FDA) regulations. Professionals in this field prepare and submit regulatory documents, monitor compliance with changing laws, and help companies navigate the approval process. They work closely with internal teams and regulatory agencies to ensure safety, efficacy, and legal adherence.

What are the main responsibilities of an FDA Regulatory?

Professionals in FDA Regulatory roles are primarily responsible for preparing, reviewing, and submitting documents to the FDA to support the approval of pharmaceuticals, medical devices, or other regulated products. You will monitor regulatory changes, ensure company practices comply with relevant laws, and serve as a liaison between your organization and the FDA. Daily tasks often involve cross-functional collaboration with research, quality assurance, and product development teams. This role is both fast-paced and detail-oriented, requiring you to manage multiple projects and adapt to evolving regulatory landscapes.

What are the key skills and qualifications needed to thrive in an FDA Regulatory position?

To thrive in an FDA Regulatory role, you must have a thorough understanding of FDA regulations, submission requirements, and scientific or technical documentation, usually supported by a degree in life sciences or a related field. Proficiency with regulatory submission software (such as eCTD), knowledge of guidance documents, and sometimes RAC certification are highly valued. Strong organizational abilities, problem-solving skills, and clear communication are essential soft skills for coordinating between internal teams and external agencies. These qualifications are vital to ensure compliance, successful product approvals, and effective interaction with regulatory authorities.

How can I get into FDA regulatory?

To enter FDA regulatory roles, candidates typically need a background in life sciences, healthcare, or engineering, along with knowledge of FDA regulations and compliance processes. Relevant experience can be gained through internships, certifications such as RAC (Regulatory Affairs Certification), or working in quality assurance or compliance departments. Strong analytical skills, attention to detail, and understanding of medical device or pharmaceutical development are also important.

What are popular job titles related to Fda Regulatory jobs in Puerto Rico?

For Fda Regulatory jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Fda Regulatory jobs in Puerto Rico look for?

The top searched job categories for Fda Regulatory jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Fda Regulatory jobs?

Cities in Puerto Rico with the most Fda Regulatory job openings:

Fda Regulatory jobs near you
Infographic showing various Fda Regulatory job openings in Puerto Rico as of August 2026, with employment types broken down into 2% As Needed, 85% Full Time, 10% Part Time, and 3% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution.

Process Development Engineer

Technical and Engineering Consulting

Dorado, PR • On-site

Full-time

Posted 11 days ago

Job description

About the Role
We are seeking an experienced Process Development Engineer to support the development, validation, optimization, and implementation of manufacturing processes within a highly regulated manufacturing environment. The selected professional will collaborate with cross-functional teams to develop robust manufacturing processes, qualify equipment, generate technical documentation, and support new product introductions while ensuring compliance with FDA and quality system requirements.
This position is ideal for engineers who enjoy working in fast-paced manufacturing environments where technical problem solving, continuous improvement, and process innovation are critical to success.
Key Responsibilities
  • Lead and support equipment qualification activities including IQ, OQ, PQ, and Process Performance Qualification (PPQ).
  • Develop validation protocols, reports, and Master Validation Plans.
  • Design and implement in-process and receiving inspection systems for new products and manufacturing processes.
  • Prepare technical documentation including:
    • Equipment evaluations
    • Preventive Maintenance (PM) procedures
    • Calibration procedures
    • Manufacturing work instructions
  • Manage process development projects from concept through implementation.
  • Partner with Manufacturing, Quality, Engineering, Automation, and Operations teams to ensure successful project execution.
  • Apply engineering tools including:
    • Design of Experiments (DOE)
    • PFMEA
    • Risk Analysis
    • Root Cause Investigations
  • Support process characterization, optimization, troubleshooting, and continuous improvement initiatives.
  • Work with advanced manufacturing technologies including:
    • Laser welding
    • Heat bonding
    • Injection molding
    • Vision inspection systems
    • Automated equipment (PLC, Servo Systems, Pneumatics, Sensors)
  • Support New Product Introduction (NPI) and process scale-up activities.
  • Ensure compliance with FDA regulations, GMP requirements, and company quality systems.
Minimum Qualifications
  • Bachelor's Degree in Mechanical Engineering or Electrical Engineering.
  • 5-7 years of manufacturing or quality engineering experience within an FDA-regulated industry.
  • Experience in Medical Devices, Pharmaceutical, Biotechnology, or Diagnostics manufacturing.
  • Strong knowledge of:
    • Equipment Qualification (IQ/OQ/PQ)
    • Process Validation
    • DOE
    • PFMEA
    • CAPA
    • Root Cause Analysis
  • Experience developing technical documentation and validation deliverables.
  • Working knowledge of:
    • 21 CFR Part 820
    • GMP
    • ISO 13485
  • Experience supporting automated manufacturing equipment and production systems.
Preferred Qualifications
  • Experience supporting New Product Introduction (NPI).
  • Experience with automated manufacturing technologies.
  • Knowledge of tooling, fixtures, and test method development.
  • Strong project management and technical leadership skills.
  • Excellent communication and cross-functional collaboration abilities.
What We're Looking For
The ideal candidate is:
  • Analytical and detail-oriented
  • Strong technical problem solver
  • Self-driven and proactive
  • Comfortable working with multidisciplinary teams
  • Committed to quality and continuous improvement
  • Able to manage multiple priorities in a fast-paced manufacturing environment
Quality Commitment
The selected candidate will demonstrate a strong commitment to patient safety, product quality, regulatory compliance, and documentation excellence while supporting all applicable Quality System requirements.

Apply