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.

Qualifications:

• Bachelor’s Degree in a related field and a minimum of 5 years of regulatory affairs experience with a medical device company required
• Experience with FDA, CE MDD/MDR, and MDSAP
• Proficient with MS Office
• Ability to create cross-functional partnerships
• Ability to work collaboratively in a team environment
• Effective verbal and written communication skills
• Effective problem-solving skills
• Ability to work in a fast-paced environment with the ability to manage multiple, simultaneous responsibilities
• Additional skills: Process improvement, analyzing information, attention to detail, thoroughness, dealing with complexity and controversy

Hours: Monday-Friday, 8:00am-5:00pm