Regulatory Compliance Specialist
hace 5 días
About the Role:
We are seeking a highly skilled Regulatory Compliance Specialist to join our team in support of the EU MDR program. As a key member of our team, you will play a critical role in ensuring compliance with regulatory requirements.
Key Accountabilities:
- Support data gathering and analysis to inform remediation plans.
- Conduct gap assessments to identify areas for improvement.
- Develop and execute remediation plans to address identified gaps.
- Maintain accurate and detailed records of all activities.
Essential Qualifications:
- Bachelor's degree in Engineering, Science, or related field.
- At least 7-10 years of experience in validation activities and/or project management.
- Strong knowledge of regulatory agency guidelines.
- Excellent analytical and problem-solving skills.
- Proficient in Microsoft Project.
Preferred Qualifications:
- Familiarity with Medical Device Regulation (MDR).
- Fluency in Spanish and English.
- Experience working in a regulated environment.
-
EU MDR Compliance Specialist
hace 2 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoWe are seeking a highly experienced EU MDR Compliance Specialist to join our team at Labchems Corp. As a critical member of our compliance team, you will be responsible for ensuring that our company remains compliant with EU MDR regulations. Your expertise in validation activities, project management, and technical documentation will be essential in...
-
Regulatory Compliance Expert
hace 2 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo**Quality System Analyst Role**We are seeking a highly skilled Quality System Analyst to join our team. As a Quality System Analyst, you will be responsible for ensuring compliance with company policies and quality standards, and developing solutions to database problems.**Responsibilities**Monitor and track all sources of quality detractors utilizing...
-
EU MDR Compliance Specialist III
hace 2 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoCompany OverviewLabchems Corp. is a leading manufacturer of high-quality laboratory chemicals and equipment. Our commitment to innovation and customer satisfaction has earned us a reputation as a trusted partner in the scientific community.Job DescriptionWe are seeking a highly skilled EU MDR Compliance Specialist III to join our team. The successful...
-
Validation Specialist for Medical Devices
hace 2 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoLabchems Corp. seeks a highly skilled Validation Specialist to join our team in supporting the EU MDR program. As a key member of our team, you will be responsible for ensuring compliance with EU MDR regulations by conducting thorough gap assessments and developing comprehensive remediation plans. Your expertise in validation activities, project management,...
-
Project Implementation Specialist
hace 18 horas
Añasco, Puerto Rico Computer Integration Of Quality Assurance Inc. A tiempo completo**Job Overview:**We are seeking a highly motivated and skilled Project Implementation Specialist to support the successful deployment of an Oracle-based on-demand label printing application at our site.**Responsibilities:* Coordinate communication between Corporate IT, Oracle implementation teams, and site stakeholders (IT, QA, and Manufacturing).* Serve as...
-
Project Management Specialist
hace 18 horas
Añasco, Puerto Rico Computer Integration Of Quality Assurance Inc. A tiempo completoJob SummaryWe are seeking a highly skilled Project Manager to lead a large-scale, multi-million-dollar project within the medical device sector. The right candidate will have extensive experience managing complex projects, budgets, cross-functional teams, and ensuring compliance with industry regulations.ResponsibilitiesDevelop comprehensive project plans,...
-
Senior Project Coordinator
hace 18 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoJob Overview: We are seeking a highly skilled Project Manager to lead our team in delivering high-quality projects within the regulated industry. As a Project Manager, you will be responsible for developing and implementing project plans, managing budgets, and ensuring regulatory compliance.Key Responsibilities:Develop comprehensive project plans that...
-
Validation and Project Manager
hace 5 días
Añasco, Puerto Rico Labchems Corp. A tiempo completoOverview:Laboratory Chemists Corporation is committed to delivering high-quality services to our clients. As part of this commitment, we are seeking a highly skilled Validation and Project Manager to join our team in support of the EU MDR program.Responsibilities:Support the development and implementation of remediation plans.Collaborate with...
-
Manufacturing Process Optimization Specialist
hace 3 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAbout the RoleThe ideal candidate will have a Bachelor's degree in Sciences or Engineering and previous exposure in Quality Engineering activities within the Medical Devices or Pharmaceutical industry. They will be responsible for investigating manufacturing product quality and compliance issues, analyzing results, making recommendations, and developing...
-
Project Manager
hace 20 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor Project Management services in the Facilities area.WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Life Sciences, Engineering, or related field and at least five (5) years of previous exposure to Project Management activities within the regulated industry.Bilingual: (Spanish and English) Shift: Administrative & according to business...
-
Quality Assurance Specialist
hace 2 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo**Company Overview**Flexible & Integrated Technical Services, LLC is a leading provider of specialized technical services across the Island and in the US. We pride ourselves on treating our resources like family and providing top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.**Job Summary**We are seeking a...
-
Maintenance and Facilities Specialist
hace 5 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAbout Us">We are Flexible & Integrated Technical Services, LLC, a service provider company that stands out from the rest.">Our company values flexibility, family orientation, and employee well-being, offering a unique blend of services across the island and in the US.">Key Responsibilities">As a Facilities Engineer, your key responsibilities will include...
-
Program Operations Director
hace 10 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoSenior Project Manager Position: We are seeking a highly experienced Senior Project Manager to lead our team. In this role, you will be responsible for overseeing multiple projects simultaneously, ensuring timely completion, and meeting client expectations.Key Responsibilities:Develop and execute project plans, including budgeting, scheduling, and resource...
-
Director of Operations
hace 11 horas
Añasco, Puerto Rico Computer Integration Of Quality Assurance Inc. A tiempo completoAbout the RoleThis Senior Project Manager position offers a unique opportunity to lead a high-visibility project within the medical device sector. As a seasoned professional, you will be responsible for managing complex projects, budgets, and cross-functional teams to ensure successful project delivery.ResponsibilitiesDevelop comprehensive project plans,...
-
Oracle Labeling System Manager
hace 11 horas
Añasco, Puerto Rico Computer Integration Of Quality Assurance Inc. A tiempo completo**Job Title:** Oracle Labeling System ManagerWe are seeking a highly experienced Oracle Labeling System Manager to join our team at Computer Integration Of Quality Assurance Inc. The ideal candidate will have a strong background in Oracle system implementation and management, as well as excellent communication and interpersonal skills.**Responsibilities:*...
-
Project Development Manager
hace 14 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoProject Management Role: We are seeking an experienced Project Manager to join our team. In this role, you will be responsible for planning, executing, and monitoring projects from start to finish. You will work closely with cross-functional teams to ensure successful project delivery.Responsibilities:Plan and coordinate project activities, including...
-
Project Validation Specialist Iii
hace 2 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoSupport the European Union Medical Device Regulation (EU MDR) program with the following activities: Data Gathering–Participate in the discovery and compilation of required documentation to be evaluated. Gap Assessments–Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production...
-
Senior Project Manager
hace 20 horas
Añasco, Puerto Rico Computer Integration Of Quality Assurance Inc. A tiempo completoJob SummaryWe are seeking a highly skilled Project Manager to lead a large-scale, multi-million-dollar project within the medical device sector. The right candidate will have extensive experience managing complex projects, budgets, cross-functional teams, and ensuring compliance with industry regulations. This role requires a proactive leader with strong...
-
Regulated Industry Coordinator
hace 15 horas
Añasco, Puerto Rico Computer Integration Of Quality Assurance Inc. A tiempo completo**Job Description:**We are looking for a Regulated Industry Coordinator to support the implementation of an Oracle-based on-demand label printing application at our Añasco site. This individual will serve as the primary liaison between Corporate IT, the Oracle implementation team, and site stakeholders including IT, QA, and Manufacturing.**Key...
-
Senior Program Lead
hace 15 horas
Añasco, Puerto Rico Computer Integration Of Quality Assurance Inc. A tiempo completoAbout UsComputer Integration Of Quality Assurance Inc. is a leading company in the medical device sector, dedicated to developing innovative solutions that improve patient outcomes. Our team is comprised of experienced professionals who share a passion for quality assurance and customer satisfaction.This role offers an exceptional opportunity to join our...