Regulatory Affairs Manager

Natrona Heights, PA

Industry: Manufacturing Job Number: Req-3700 Pay Rate: Negotiable

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 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

JH Technical Services

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