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