Manager - Regulatory Compliance

• Quality Management System implementation and Monitoring
• Support Regulatory Decisions, Product Registration, Plant Registration & Device Listing
• Advice Production and Process Change Regulatory Requirements
• Responsible for Internal and External Audits
• Responsible for the customer complaints handling and Quality feedback (QFB) subsystem at CR Manufacturing Site
• Responsible for Management Review activities
• Responsible for the Document and Change Control Management System
• Responsible for the Risk Management System activities
• Revision and Approval of NCR, CAPAs, QFB, Customer Complaints and other quality documentation as required.
• Identification, traceability, and periodic review of Regulatory Requirements
• Monitor Quality Systems Indicators at areas of responsibility.
• Perform the revision and approval of Global and Local Procedures
• Perform the Regulatory affairs impact document (RAID) for the CR Rite
• Provide training on Quality System Regulations including Internal Audits, Regulatory Compliance, GMP’s and GDP’s trainings.
• Analyzing problems through a structured approach to identify root causes.
• Lead site quality & compliance culture program
• Lead improvement activities for Quality System issues
• Assure Compliance with Laws & Regulations
• Assure Adherence to CooperVision Values
• People Development
• Vacations & Overtime Administration for exempts
• Purchasing Requisitions issue and approval
• RC Budget creating and control.

• Complies with the Quality Systems Regulations and the Safety and Health policies and procedures.

  CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Knowledge, Skills and Abilities:

• Strong Knowledge of GMPs/QSR.
• Strong Knowledge on ISO13485, 21 CFR 820, EU MDR, QMS and MDSAP
• Excellent oral and written communication skills in English and Spanish
• Service oriented
• Computer literate, with a working knowledge of software programs such as Microsoft Office (Word, PowerPoint, Excel)
• Excellent organization skills
• Ability to handle, organizes, and follows up multiple tasks.
• Must be a team player.
• Must be able to work under pressure.
• Effective people management skills in a team working culture

Work Environment:

• Generally, works in a closed environment, in office conditions, with loud level of noise and controllable changes of temperature.
• Needs to stand, walk, and may be seated for a long period of time.
• Uses hands to feel, finger or handle and reach.
• Works with a personal computer and programs to prepare documents or reports.
• Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others.
• Needs to have high analytical capacity and level of professionalism and judgment to resolve problems

Experience:

• Minimum of five years of experience in Quality/Regulatory Compliance in a regulated industry, preferable medical device/pharmaceutical industry in a similar position
• Demonstrated knowledge and application experience of the FDA Quality System Regulation (21CFR Part 820) and related regulations, as well as knowledge in all major manufacturing processes and support systems.
• Certified Quality Auditor
• Willing to travel

Education:

• Bachelor’s degree in science, Engineering, Management, or related field

Regulation Requirements

Quality System Responsibilities

1. Complies with the Quality System Regulation (QSR)

2. Executes job responsibilities as established in the Standard Operating Procedures (SOP)

3. Follows the documentation procedures.

Safety & Occupational Health Responsibilities

1. Complies with Safety and Occupational Health Policy and procedures.

2. Complies with Hazardous Communication program.

3. Notifies immediately all accidents or incidents occurred in work area.

4. Promotes and maintains a safe working area and notifies any condition he/she may think might cause an accident.

5. Participates in the activities of the Safety and Occupational Health Program as requested.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. CooperVision, Inc. reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.