Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. * Proven experience leading FCA and CAPA processes, ideally within a ...
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. * Proven experience leading FCA and CAPA processes, ideally within a ...
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
Quick apply
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
Quick apply
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
Quick apply
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
Quick apply
PR · On-site
Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal audits and regulatory inspections as the Subject Matter Expert (SME) for Cleaning Validation. General ...
$20.25 - $28/hr
Provide technical support for the maintenance team during FDA and other regulatory agency inspections. * Provide technical support to the maintenance team in response to the FDA and other regulatory ...
Quick apply
$20.25 - $28/hr
Provide technical support for the maintenance team during FDA and other regulatory agency inspections. * Provide technical support to the maintenance team in response to the FDA and other regulatory ...
PR · On-site
Provide technical support for the maintenance team during FDA and other regulatory agency inspections. * Provide technical support to the maintenance team in response to the FDA and other regulatory ...
Quick apply
PR · On-site
Provide technical support for the maintenance team during FDA and other regulatory agency inspections. * Provide technical support to the maintenance team in response to the FDA and other regulatory ...
Sr. Opex Engineer
$98K - $135K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Sr. Opex Engineer
$98K - $135K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior OpEx Engineer
$85K - $117K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior OpEx Engineer
$85K - $117K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior Opex Engineer
$99K - $136K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior Opex Engineer
$99K - $136K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior Opex Engineer
Aibonito, PR · On-site
$99K - $136K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior Opex Engineer
Aibonito, PR · On-site
$99K - $136K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior Opex Engineer
Aibonito, PR · On-site
$99K - $136K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
Senior Opex Engineer
Aibonito, PR · On-site
$99K - $136K/yr
Ensure compliance with internal policies, cGMP, FDA regulations, and external standards through robust process improvements. * Collaborate with global and divisional teams to share best practices and ...
PR · On-site
$80 - $110/hr
Regulatory knowledge (FDA, GxP, Part 11) * Large team leadership (50+ preferred) * Agile & Waterfall experience * Enterprise-scale program delivery * Willing to travel to Puerto Rico Preferred * PMP ...
Quick apply
PR · On-site
$80 - $110/hr
Regulatory knowledge (FDA, GxP, Part 11) * Large team leadership (50+ preferred) * Agile & Waterfall experience * Enterprise-scale program delivery * Willing to travel to Puerto Rico Preferred * PMP ...
Senior Engineering/ IT Program Manager
Ponce, PR · On-site +1
$113K - $113K/yr
Regulatory knowledge (FDA, GxP, Part 11) * Large team leadership (50+ preferred) * Agile & Waterfall experience * Enterprise-scale program delivery * Willing to travel to Puerto Rico Preferred * PMP ...
Senior Engineering/ IT Program Manager
Ponce, PR · On-site +1
$113K - $113K/yr
Regulatory knowledge (FDA, GxP, Part 11) * Large team leadership (50+ preferred) * Agile & Waterfall experience * Enterprise-scale program delivery * Willing to travel to Puerto Rico Preferred * PMP ...
Strong knowledge of: * cGMP / FDA regulations * Cleaning validation lifecycle and strategies * Data integrity principles (ALCOA+) * Experience with: * Protocol and report generation (IQ/OQ/PQ / CV)
Strong knowledge of: * cGMP / FDA regulations * Cleaning validation lifecycle and strategies * Data integrity principles (ALCOA+) * Experience with: * Protocol and report generation (IQ/OQ/PQ / CV)
Follows all Good Manufacturing Practices and SOP's as defined by Viant's policies, practices and procedures to ensure that FDA regulations, GMP, ISO13485, and Viant quality standards are met.
Follows all Good Manufacturing Practices and SOP's as defined by Viant's policies, practices and procedures to ensure that FDA regulations, GMP, ISO13485, and Viant quality standards are met.
Follows all Good Manufacturing Practices and SOP's as defined by Viant's policies, practices and procedures to ensure that FDA regulations, GMP, ISO13485, and Viant quality standards are met.
Follows all Good Manufacturing Practices and SOP's as defined by Viant's policies, practices and procedures to ensure that FDA regulations, GMP, ISO13485, and Viant quality standards are met.
In-depth knowledge of GMP, FDA regulations, and industry standards. * Experience writing and executing qualification protocols. * Excellent problem-solving and troubleshooting skills. * Strong ...
Quick apply
In-depth knowledge of GMP, FDA regulations, and industry standards. * Experience writing and executing qualification protocols. * Excellent problem-solving and troubleshooting skills. * Strong ...
Follows all Good Manufacturing Practices and SOP's as defined by Viant's policies, practices and procedures to ensure that FDA regulations, GMP, ISO13485, and Viant quality standards are met.
Follows all Good Manufacturing Practices and SOP's as defined by Viant's policies, practices and procedures to ensure that FDA regulations, GMP, ISO13485, and Viant quality standards are met.
The Principal Investigator is responsible for ensuring subject safety, protocol compliance, data integrity, and high-quality study execution in accordance with FDA regulations, ICH-GCP guidelines ...
The Principal Investigator is responsible for ensuring subject safety, protocol compliance, data integrity, and high-quality study execution in accordance with FDA regulations, ICH-GCP guidelines ...
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:
Contractor
Posted 27 days ago
Job description
For Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
The Personality Part:
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
WHO WE ARE:
We are a Service Provider company, different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree in Engineering or Science and eight (8) years of exposure within the Medical Devices Industry, with a strong background in field corrective actions, CAPA, or product quality management.
- Bilingual: Spanish and English
- Soft Skills: Excellent teamwork skills
- Shift: 1st, and according to business needs.
- Experience in:
- Experience in equipment IQ, OQ, and PQ and/or process validation.
- Process Validation Lifecycle.
- Preferred experience in DOE.
- Computer and software validation, SOP Development, Change control of Medical Devices
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
- Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods to identify, implement, and maintain the procedures.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
- Performs system administration and configuration of quality information technology systems.
- Quality role to support product transfer activities, focus on sterilization machines, validation, and process.
- Experience with process failure mode analysis and first-time quality.
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
- Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
- Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
- Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
- Proficiency in quality management systems. Strong technical writing capability.
WHO WE ARE:
We are a Service Provider company, different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?