- Regulatory Compliance Manager
- Liaison with RA and MFG Operation sites QA Leaders.
- Collaborate with RA to align manufacturing with regulatory submissions and strategies, including new regulatory requirements, deficiency management, and remediation activities to ensure compliance with external requirements such as the MDR.
- Ensure consistency and adherence to global quality standards and regulatory requirements across all manufacturing sites.
- Supervise and guide contractors to ensure alignment with project goals and objectives.
- Develop and implement processes to gather information about potential risks for prompt resolution.
- Conduct investigations into any potential or actual deficiencies or deviations from requirements.
- Support the enhancement of the company's quality system, working with employees to ensure ISO 13485, MDSAP, and FDA QSR compliance for devices.
- Review, revise, and update policies, procedures, and guidelines to ensure compliance with current requirements and regulations.
- Enhance knowledge by educating teams on regulatory requirements.
- Excellent oral/written communication skills in English and Spanish.
- Ability to comprehend highly technical material.
- Proficient knowledge of Medical Devices quality standards and regulations (GMPs/QSR) and best practices.
- Leadership, collaboration, and teamwork.
- Intermediate skill in Excel, Word, and PowerPoint; advanced skills preferred.
- Analytical and critical thinking skills.
- Strong organizational and time-management skills.
- Project and resource management.
- Conflict resolution abilities.
- Ability to train and educate others.
- Initiative-taking, self-starter, and responsible individual.
- 5+ years of experience in a medical device role similar to this position.
- Bachelor's degree in business administration or science or related experience in a regulatory compliance setting.
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LL03-020524 - Regulatory Compliance Manager - Juana Díaz, Puerto Rico - Validation & Engineering Group, Inc
Descripción
Department: Field - LLLocation: , Juana Diaz
Validation & Engineering Group, Inc. (V&EG) is a respected services provider offering solutions for industries like Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices. They specialize in Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and related services.
We are on the lookout for a skilled and dedicated individual who is committed to working with the highest ethical standards for the position of:
This role is primarily focused on providing specialized assistance to the Regulatory Affairs department regarding EU MDR certification for manufacturing sites. It involves collaborating with the EU MDR Regulatory Affairs department, overseeing compliance activities within global manufacturing operations, managing contractors, and ensuring alignment with regulatory standards.
Job Summary:
The Regulatory Compliance Manager, reporting to the Global Quality Assurance department, plays a crucial role in supporting the Regulatory Affairs team in obtaining EU MDR certification for manufacturing operations. This position oversees two contractors, ensuring compliance within manufacturing operations, and collaborates closely with cross-functional teams to address deficiencies and maintain regulatory conformity.
Essential Functions & Accountabilities:
Qualifications:
Experience:
Education:
