Regulatory Affairs Manager

A medical device company, located northeast of Pittsburgh, is seeking a Regulatory Affairs Manager.

Responsibilities:

• Responsible for maintaining a cGMP compliant Quality Management System for a Medical Device manufacturer's implemented systems to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, CE MDD 93/42/EEC, and ISO 13485:2016 regulatory requirements.
• Management of the Regulatory environment including the FDA, CE, and related country regulatory requirements globally.
• Prepare and maintain regulatory submissions.
• Maintain country specific product registrations.
• Analyze product changes for impact to current regulatory filings.
• Monitor industry regulations and standards for changes and assess impacts to company.
• Develop relevant regulatory procedures and work instructions as necessary.
• Ensure conformance to ISO, CE, FDA and other international/local regulations.
• Investigate and document issues relating to the product, process, or Quality System relevant to the regulatory compliance.
• Participate in regulatory audits.
• Notified Body interaction including required submittals and/or transfers.
• Limited travel may be required either domestically or internationally.