Regulatory Affairs and Compliance Manager
MANAGER - REGULATORY AFFAIRS AND COMPLIANCE. (work location in Houston, TX or Pennsylvania)
Excellent opportunity available for a Regulatory Affairs and Compliance Manager to lead regulatory efforts to prepare the company to manufacture and/or distribute pharmaceutical products and medical devices. The Manager, Regulatory Affairs & Compliance will interact locally with pharmaceutical manufacturing efforts and with contract manufacturing of a class II medical device. The Manager, Regulatory affairs & Compliance will assist the quality systems leadership to prepare or modify SOP's in order to achieve FDA compliance for expected new products. The Manager, Regulatory Affairs & Compliance will be located in TX or PA.
Responsibilities of the Manager, Regulatory Affairs & Compliance responsibilities include:
- Organize and submit medical device and drug approval filings with the US Food and Drug Administration (FDA) to obtain approval in a timely fashion.
- Create, execute, and review product qualification and process validation protocols required to support FDA submissions.
- Lead company efforts for FDA Track and Trace regulations including leading efforts for system selection and SOP generation.
- Submit adverse event reports for all products, both drug and medical device as required.
- Provide regulatory inputs in the investigation of customer complaints.
Skills Requirements include:
- Bachelor's degree in Mechanical, Biomedical, or Electrical Engineering or equivalent experience.
- Minimum of 3 years of experience in US FDA regulatory affairs, ideally related to Class II or higher medical devices which contain software and with pharmaceutical products.
- Complete knowledge of US FDA Medical Device regulations and ISO 13485
- Demonstrated experience and ability to create submissions for FDA class II medical devices with experience with Class III a plus.
- Knowledge of quality system requirements for pharmaceuticals and medical devices, including design controls, supplier contracts, and maintaining contract manufacturers. Responsible for creating documents to execute these activities working with local quality systems leadership.
- Knowledge of and experience in executing risk or hazard assessments for medical devices including but not limited to assessment of hardware and software changes.
- Ability to travel as required up to 20% including international travel as required.