Electrical Engineer
Salinas, PR · On-site
Design, install, maintain, and troubleshoot electrical systems and equipment in compliance with industry standards and FDA regulations. * Collaborate with project teams, engineers, and production ...
Electrical Engineer
Salinas, PR · On-site
Design, install, maintain, and troubleshoot electrical systems and equipment in compliance with industry standards and FDA regulations. * Collaborate with project teams, engineers, and production ...
Design, install, maintain, and troubleshoot electrical systems and equipment in compliance with industry standards and FDA regulations. * Collaborate with project teams, engineers, and production ...
Design, install, maintain, and troubleshoot electrical systems and equipment in compliance with industry standards and FDA regulations. * Collaborate with project teams, engineers, and production ...
Sr Quality Operations Manager
Juncos, PR · On-site
Previous experience leading FDA & Regulatory Bodies inspections / Audits. * Regulatory experiences. Physical Job Requirements The above statements are intended to describe the general nature and ...
Sr Quality Operations Manager
Juncos, PR · On-site
Previous experience leading FDA & Regulatory Bodies inspections / Audits. * Regulatory experiences. Physical Job Requirements The above statements are intended to describe the general nature and ...
Porfolio Manager
Gurabo, PR · On-site
Ensure compliance with FDA regulations , GMP standards, and industry best practices. * Lead risk management and mitigation strategies across the portfolio. * Support resource planning and capacity ...
Porfolio Manager
Gurabo, PR · On-site
Ensure compliance with FDA regulations , GMP standards, and industry best practices. * Lead risk management and mitigation strategies across the portfolio. * Support resource planning and capacity ...
PR · On-site
Medical
Dental
Vision
... FDA regulatory requirements · Identify opportunities for process automation and operational efficiency · Assist in change management and system adoption across the organization Experience and ...
Quick apply
PR · On-site
Medical
Dental
Vision
... FDA regulatory requirements · Identify opportunities for process automation and operational efficiency · Assist in change management and system adoption across the organization Experience and ...
PR · On-site
Ensure compliance with applicable global regulatory requirements (FDA, cGMP, ICH, and internal quality standards). * Support periodic reviews, requalification activities, and lifecycle management of ...
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PR · On-site
Ensure compliance with applicable global regulatory requirements (FDA, cGMP, ICH, and internal quality standards). * Support periodic reviews, requalification activities, and lifecycle management of ...
PR · On-site
Ensure compliance with applicable global regulatory requirements (FDA, cGMP, ICH, and internal quality standards). * Support periodic reviews, requalification activities, and lifecycle management of ...
Quick apply
PR · On-site
Ensure compliance with applicable global regulatory requirements (FDA, cGMP, ICH, and internal quality standards). * Support periodic reviews, requalification activities, and lifecycle management of ...
PR · On-site
Ensure compliance with applicable global regulatory requirements (FDA, cGMP, ICH, and internal quality standards). * Support periodic reviews, requalification activities, and lifecycle management of ...
Quick apply
PR · On-site
Ensure compliance with applicable global regulatory requirements (FDA, cGMP, ICH, and internal quality standards). * Support periodic reviews, requalification activities, and lifecycle management of ...
Deviations Owner
Juncos, PR · On-site
Strong understanding of GMP, FDA regulations, and quality systems. * Proficiency in English; additional language skills are a plus. * Experience with deviation tracking systems, CAPA management, and ...
Deviations Owner
Juncos, PR · On-site
Strong understanding of GMP, FDA regulations, and quality systems. * Proficiency in English; additional language skills are a plus. * Experience with deviation tracking systems, CAPA management, and ...
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
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PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
C&Q Specialist | Pharmaceutical
Guaynabo, PR · On-site
$82.66 - $123.98/hr
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
C&Q Specialist | Pharmaceutical
Guaynabo, PR · On-site
$82.66 - $123.98/hr
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
Quick apply
PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
Quick apply
PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
Quick apply
PR · On-site
Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines. * Support the periodic review and requalification of pharmaceutical systems. * Coordinate system ...
Quality - Quality Compliance Supervisor
Medical
Dental
Vision
Life
Retirement
PTO
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
Quality - Quality Compliance Supervisor
Medical
Dental
Vision
Life
Retirement
PTO
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
Quality - Quality Compliance Supervisor
Medical
Dental
Vision
Life
Retirement
PTO
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
Quality - Quality Compliance Supervisor
Medical
Dental
Vision
Life
Retirement
PTO
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
Quality - Quality Compliance Supervisor
Medical
Dental
Vision
Life
Retirement
PTO
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
Quality - Quality Compliance Supervisor
Medical
Dental
Vision
Life
Retirement
PTO
... FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. • Establishes and ensures maintenance of ...
Process Validation Specialist
Juncos, PR · On-site
Knowledge of GMP, FDA regulations, and quality systems. * Proficiency in English; additional language skills are a plus. * Strong analytical, organizational, and problem-solving skills. * Excellent ...
Process Validation Specialist
Juncos, PR · On-site
Knowledge of GMP, FDA regulations, and quality systems. * Proficiency in English; additional language skills are a plus. * Strong analytical, organizational, and problem-solving skills. * Excellent ...
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 ...
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 ...
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:
Job description
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Qualifications / Requirements / Knowledge / Education / Skills:
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Responsibilities:
- Design, install, maintain, and troubleshoot electrical systems and equipment in compliance with industry standards and FDA regulations.
- Collaborate with project teams, engineers, and production personnel to ensure electrical systems support operational requirements efficiently.
- Conduct root cause analysis for electrical failures or deviations and implement corrective actions.
- Ensure compliance with electrical codes, safety standards, and company procedures.
- Prepare and maintain accurate documentation, schematics, and records of electrical systems, maintenance, and modifications.
- Support validation and qualification activities for electrical equipment in regulated environments.
- Participate in audits and inspections, providing technical support and evidence of compliance.
Qualifications / Requirements / Knowledge / Education / Skills:
- Bachelor's degree in Electrical Engineering or a related field.
- Minimum of 5-10 years' experience in electrical engineering, maintenance, or project support, preferably in FDA-regulated or life sciences environments.
- Strong knowledge of electrical systems, controls, PLCs, and instrumentation.
- Understanding of GMP, FDA regulations, and quality systems is a plus.
- Proficiency in English; additional language skills are a plus.
- Experience with CAD, electrical schematics, and preventive maintenance planning.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication skills and ability to work collaboratively in multidisciplinary teams.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
About Mentor Technical Group
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