Job Summary: This position will be responsible for managing and facilitating Post Market Surveillance (PMS) activities supporting Regulatory Compliance Management and for facilitating regulatory compliance pursuant to federal, international, corporate regulatory requirements and standards.
Provide regulatory support in the area of Post Market Surveillance activities.
Ensure PMS plans and reviews are completed as scheduled through project management.
Scheduling and coordinating Post Market Surveillance Review meetings consistent with time scales determined by the PMS plan.
Communicate requirements to the Post Market Surveillance team members responsible for the PMS planning and reviews.
Review and interpret data for documentation as needed.
Write and present summaries and reports.
Provide regulatory support for 3rd party audits (FDA, Notified Body) throughout the corporation as needed.
Responsible for defining, implementing and follow-up of systematic corrective and preventive actions (CAPA) when applicable.
Perform or assist on internal audits as needed in order to ensure compliance with federal and international regulatory and quality system requirements.
Job Specifications: Requires the ability to
- Respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Skills And Abilities:
- Knowledge and skills identified are typically acquired by completing a Bachelors degree; preferably.
- Five (5) years of practical medical device manufacturing experience preferred.
- ASQ Certified Biomedical Auditor (CBA) will be required.
- A working knowledge of FDA and regulations and how to interpret and monitor them with experience or knowledge in Quality Systems relating to 21 QSR Parts 11 / 820 and ISO 13485:2003.
- Knowledge of CAPA, Quality Planning, Process Validation and Quality Auditing. Computer skills required, including Microsoft Excel, Powerpoint and Word. AS/400 and/or Infor XA experience is a plus.
- Knowledge or ability to gain proficient knowledge of current Good Manufacturing Practices (GMP/QSR) for medical device industry
- Intermediate computer skills required, including Sharepoint, Microsoft Excel, Word and PowerPoint
- Ability to appropriately function within multiple electronic/enterprise systems in use by the department.
- Strong written and verbal communication skills
- Strong interpersonal skills
- Excellent organizational and time management skills.
- Understanding of basic management skills including, but not limited to task delegation, scheduling and prioritization
- Analytical skill is essential.
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