Regulatory Affairs Associate Conshohocken, PA

Found in: CMP US C2 - 2 weeks ago

Conshohocken, United States Healthcare Recruitment Counselors Full time
Regulatory Affairs Associate Conshohocken, PA
We are looking for a Regulatory Affairs Associate to join our company full time in Conshohocken, PA. This position requires the incoming candidate to be onsite, 5 days per week at our office in Conshohocken. The Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system. Ideally, the incoming Associate has excellent attention to detail and organizational skills, can work independently & in a team environment, is able to multi-task, and has effective verbal and written communication skills. Must have extensive knowledge of applicable government regulations.
Duties & Responsibilities:
  • Generate audit agenda, plan, summary report, and perform internal audits
  • Assist with supplier qualification for vendors, customers, consultants, and other services (as appropriate)
  • Initiate and investigate quality events
  • Assist with quality event reportability determination to FDA/AATB
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Support submissions of FDA/AATB reportable events
  • Assist with state license application submissions and renewals
  • Support development of validation protocols to verify compliance with regulatory requirements.
  • Support new projects and product development
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards
  • File and maintain records in accordance with standard operating procedures.
  • Perform other related duties as assigned
Requirements:
  • Bachelor’s degree in a biological science or related field required
  • At least 3 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field)
  • Extensive Knowledge of applicable government regulations
Salary:
  • $65k +(Depends on Experience)
Benefits:
  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance
Ready to join a fast growing, supportive team in an excellent working environment? We need an organized team player with a great attitude to do whatever needs to get done We offer competitive pay with great benefits and the chance to grow with us If you are interested, please contact us. We look forward to hearing from you.
HCRC Staffing

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