Regulatory Compliance Manager

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Regulatory Compliance Manager

It will primarily focus on providing specialized support to the regulatory Affairs department regarding EU MDR certification for manufacturing sites. Collaborate with EU MDR Regulatory Affairs department. This role oversees compliance activities within manufacturing operations globally, managing contactors and driving efforts to address deficiencies in alignment with regulatory standards.

Job Summary:

The Regulatory Compliance Manager, reporting to the Global Quality Assurance department, plays a pivotal role in supporting Regulatory affairs team in achieving EU MDR certification for manufacturing operations. This role oversees two contractors and focuses on ensuring compliance within manufacturing operations, collaborating closely with cross-functional teams to resolve deficiencies and maintain regulatory conformity.

Essential Functions & Accountabilities:

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 global quality standards and regulatory requirements consistency and adherence across all manufacturing sites.

Supervise and guide contractors, ensuring alignment with project goals and objectives.

Developing and implementing processes for gathering information about potential risks to ensure promptly resolution.

Conducting investigations into any potential or actual deficiency or deviation to a requirement

Support the improvement of the Company’s quality system, and work in conjunction with the company employees to ensure ISO 13485, MDSAP, and FDA QSR compliance for devices.

Reviewing, revising, and updating policies, procedures, and guidelines to ensure that they comply with current requirements and regulations.

Enhance knowledge by educating teams on regulatory requirements.

Qualifications:

Excellent in oral/ written communication skills in both English and Spanish languages.

Ability to read and understand highly technical material.

Proficient knowledge of Medical Devices quality standards and regulations (GMPs/QSR) and best practices.

Leadership, collaborative and collaborative.

Intermediate skill in the use of Excel, Word, and PowerPoint; advanced preferred.

Analytical and critical thinking skills.

Strong organizational and time-management skills.

Project and resources management

Conflict resolution skill

Ability to train and educate others.

Initiative-taking, self-starter, and responsible person.

Experience:

5+ years or more experience in a medical device in a similar position.

Education:

Bachelor’s degree in business administration or science or related experience in regulatory compliance environment.