You will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and R&D teams to ... Direct and manage all Microbiology and Chemistry Laboratory operations. * Coordinate laboratory ...
You will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and R&D teams to ... Direct and manage all Microbiology and Chemistry Laboratory operations. * Coordinate laboratory ...
Director, Quality Data Analytics
$166K - $228K/yr
Strong knowledge and expertise in Quality Management Systems and regulatory standards. * Experience supporting regulatory inspections and audits. * Experience in the medical device industry.
Director, Quality Data Analytics
$166K - $228K/yr
Strong knowledge and expertise in Quality Management Systems and regulatory standards. * Experience supporting regulatory inspections and audits. * Experience in the medical device industry.
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer.
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer.
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer.
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer.
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer.
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
Sr Quality Engineer.
Humacao, PR · On-site
$89K - $121K/yr
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management. * Knowledge of validation ...
... quality assurance is conducted prior to go-live. * Participate in the Regulatory Change Management (RCM) Committee meetings, present regulatory updates and engage subject matter experts (SME'
... quality assurance is conducted prior to go-live. * Participate in the Regulatory Change Management (RCM) Committee meetings, present regulatory updates and engage subject matter experts (SME'
... quality assurance is conducted prior to go-live. * Participate in the Regulatory Change Management (RCM) Committee meetings, present regulatory updates and engage subject matter experts (SME'
... quality assurance is conducted prior to go-live. * Participate in the Regulatory Change Management (RCM) Committee meetings, present regulatory updates and engage subject matter experts (SME'
They are responsible for all aspects of safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream as measured by safety, quality, delivery ...
They are responsible for all aspects of safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream as measured by safety, quality, delivery ...
They are responsible for all aspects of safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream as measured by safety, quality, delivery ...
They are responsible for all aspects of safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream as measured by safety, quality, delivery ...
PR · On-site
$80 - $110/hr
Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership * Manage enterprise engineering programs * Build roadmaps, milestones, and resource plans * Deliver within scope ...
Quick apply
PR · On-site
$80 - $110/hr
Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership * Manage enterprise engineering programs * Build roadmaps, milestones, and resource plans * Deliver within scope ...
Senior Engineering/ IT Program Manager
Ponce, PR · On-site +1
$113K - $113K/yr
Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership * Manage enterprise engineering programs * Build roadmaps, milestones, and resource plans * Deliver within scope ...
Senior Engineering/ IT Program Manager
Ponce, PR · On-site +1
$113K - $113K/yr
Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership * Manage enterprise engineering programs * Build roadmaps, milestones, and resource plans * Deliver within scope ...
... quality management. 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 ...
... quality management. 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 ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable ...
Project Manager
Guaynabo, PR · On-site
Your work will help maintain program quality, regulatory compliance, operational efficiency, and ... The Project Manager serves as the Deputy to the Program Manager and provides leadership for the day ...
Project Manager
Guaynabo, PR · On-site
Your work will help maintain program quality, regulatory compliance, operational efficiency, and ... The Project Manager serves as the Deputy to the Program Manager and provides leadership for the day ...
Project Manager
Guaynabo, PR · On-site
Your work will help maintain program quality, regulatory compliance, operational efficiency, and ... The Project Manager serves as the Deputy to the Program Manager and provides leadership for the day ...
Project Manager
Guaynabo, PR · On-site
Your work will help maintain program quality, regulatory compliance, operational efficiency, and ... The Project Manager serves as the Deputy to the Program Manager and provides leadership for the day ...
... Quality, Regulatory, Technical, Supply Chain, along with the TPM sites. * Ensures that bulk drug ... Generates detailed change management plans related to TPM plants changes to ensure intended results ...
Quick apply
... Quality, Regulatory, Technical, Supply Chain, along with the TPM sites. * Ensures that bulk drug ... Generates detailed change management plans related to TPM plants changes to ensure intended results ...
Quality Regulatory Manager information
What is a quality regulatory manager?
A Quality Regulatory Manager is a professional responsible for ensuring that a company's products and processes comply with industry regulations, standards, and quality requirements. They oversee the implementation of quality management systems, prepare for regulatory audits, and keep the organization updated on changing regulations. This role often involves working closely with various departments to ensure documentation, processes, and products meet both internal and external compliance standards. Quality Regulatory Managers play a critical part in maintaining the company's reputation and ability to operate within legal guidelines.
How does a quality regulatory manager typically collaborate with cross-functional teams to ensure compliance?
A Quality Regulatory Manager works closely with departments such as manufacturing, R&D, and supply chain to interpret and implement regulatory requirements across the organization. Regular meetings and clear communication are essential to align quality systems with evolving regulations and address compliance gaps. The manager often leads training sessions, reviews documentation, and coordinates audits, ensuring all teams understand and adhere to quality standards. This collaborative approach helps maintain product safety and supports successful regulatory submissions.
What are the key skills and qualifications needed to thrive as a quality regulatory manager, and why are they important?
To thrive as a Quality Regulatory Manager, you need in-depth knowledge of quality management systems, regulatory compliance, and industry standards, typically backed by a relevant degree and experience in regulated environments. Familiarity with ISO standards, FDA regulations, audit management tools, and certifications like CQE or RAC is highly valued. Strong analytical thinking, attention to detail, and effective communication are critical soft skills for collaborating across departments and ensuring compliance. These skills and qualifications are essential to maintain product quality, meet regulatory requirements, and mitigate compliance risks within an organization.
What is the difference between Quality Regulatory Manager vs Quality Assurance Specialist?
| Aspect | Quality Regulatory Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | ISO 13485, Regulatory Affairs certifications | ISO 9001, QA certifications |
| Work Environment | Regulatory agencies, compliance departments | Manufacturing, production, quality labs |
| Employer & Industry Usage | Medical devices, pharmaceuticals, biotech | Manufacturing, consumer products, electronics |
The Quality Regulatory Manager focuses on ensuring products meet regulatory standards and manages compliance documentation, often working closely with regulatory agencies. In contrast, the Quality Assurance Specialist primarily ensures product quality through testing and process audits. Both roles require quality certifications but differ in their focus areas and work environments.
What job categories do people searching Quality Regulatory Manager jobs in Puerto Rico look for?
The top searched job categories for Quality Regulatory Manager jobs in Puerto Rico are:
Job description
This is whereyour work makes a difference.
At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your Team
As the QC Manager, you will lead and organize the operations of the Microbiology and Chemistry Laboratories. You will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and R&D teams to ensure laboratory testing activities are executed in compliance with FDA regulations, USP standards, company policies, and current Good Manufacturing Practices (cGMPs).
This role is responsible for the development and implementation of laboratory policies, systems, procedures, specifications, and testing programs for Raw Materials, In-Process Materials, Finished Products, Stability Programs, and Method Transfers. You will also oversee laboratory validation activities, quality monitoring programs, and change control processes to support business priorities, quality objectives, and operational excellence.
What You'll Be DoingLaboratory Leadership & Operations- Direct and manage all Microbiology and Chemistry Laboratory operations.
- Coordinate laboratory activities with Manufacturing and Supply Chain teams.
- Lead, supervise, train, and develop exempt and non-exempt laboratory personnel.
- Ensure laboratory services are delivered efficiently, cost-effectively, and in compliance with applicable regulations and standards.
- Perform weekly, monthly, and annual reporting as required by site leadership and company procedures.
- Ensure compliance with all applicable FDA, USP, OSHA, EPA, cGMP, corporate, federal, and state requirements.
- Establish, implement, and maintain laboratory standard operating procedures and policies.
- Conduct and approve laboratory investigations, including root cause analysis activities.
- Conduct trend analysis, including Annual Product Review data evaluations.
- Ensure all laboratory changes are appropriately managed through the change control system.
- Maintain accountability for the Product Stability Program.
- Manage the laboratory validation program, including equipment, processes, test methods, software, and related systems.
- Lead and support method transfer activities where applicable.
- Participate in process validation and revalidation programs.
- Oversee testing and analysis of validation samples.
- Support continuous improvement initiatives through laboratory automation and testing method enhancements.
- Ensure laboratory analysts are properly trained and qualified to perform testing activities.
- Verify adherence to Good Laboratory Practices, company standards, and regulatory requirements.
- Routinely audit analyst performance, testing accuracy, and documentation practices to assess training effectiveness and compliance.
- Develop and manage departmental operating and capital budgets.
- Maintain laboratory technologies, software, and equipment in an updated state.
- Prepare and submit capital expenditure requests as needed.
- Ensure all laboratory service contracts are maintained and current.
- Evaluate and manage laboratory maintenance service suppliers.
- Bachelor's degree in Chemistry, Microbiology, or a related scientific discipline.
- Minimum of 8 years of experience in Quality Systems within a regulated environment.
- Minimum of 3 years of management or supervisory experience in a laboratory setting.
- Experience with wet chemistry and/or microbiology laboratory procedures.
- Root Cause Analysis training and practical experience.
- Working knowledge of applied statistics and statistical tools.
- Strong understanding of FDA regulations, USP standards, cGMPs, laboratory operations, and quality systems.
- Experience with laboratory validation programs, method transfers, and stabil
- Proven ability to train, motivate, coach, and develop employees.
- Strong presentation and communication skills.
- Demonstrated success in change management and leading organizational change.
- Demonstrated commitment to integrity, accountability, teamwork, collaboration, and performance excellence.
- Strong facilitation and conflict resolution skills.
- Fully bilingual in English and Spanish.
- Ability to effectively communicate and present information to management, customers, and regulatory auditors.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.