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
Additional Salary Information: Salary commensurate with experience
About JH Technical Services, Inc.
JH Technical Services, Inc. / JH Staffing Services was founded in 1996 and is headquartered in Pittsburgh, PA. JH has become one of the area’s fastest growing and most respected staffing firms, and is focused on assisting both clients and candidates throughout the tri-state area. We offer contract, contract to hire, and permanent placement options. The industries that we specialize in include the following: Engineering, Architecture, Information Technology, Construction, Energy, Manufacturing, and Professional/Office. The Right Recruiter. The Right Measurements. The Right Candidates.