REGULATORY AFFAIRS MANAGER

We are in search of a Regulatory Affairs Manager to join our organization at our headquarters in Malvern, PA, but also supporting our UK medical business. This is the primary regulatory role in the organization, responsible for global submissions, compliance, and interpretation. The person in this role will support our many and diverse existing and planned business initiatives. This role offers high visibility, exposure to international regulatory standards, the chance to lead a function, the opportunity to create and implement a regulatory strategy.

Main Responsibilities:


  • Develop and implement global regulatory strategy aligned with business strategy.
  • Monitor external regulation developments, identify risks, and communicate potential courses of action to management.
  • Prepare and submit regulatory approval documents. Develop and maintain strong professional relationships with regulatory agencies in order to facilitate the submission process and to efficiently manage periodic inquiries that might arise.
  • Provide input regarding conducting of clinical trials and data collection.
  • Review product and process change proposal for impact on existing regulatory approvals, clearances, and notification requirements. Assure compliance to regulatory and company design control requirements.
  • Serve as the technical expert in maintaining and building a regulatory library of products for all domestic and international regulatory requirements (FDA, CE, OSHA, ISO, EMC, FCC, etc.).
  • Partner with Quality Assurance, Engineering, Microbiology, R&D, Marketing, Sales and other departments to ensure the company is fully compliant with its regulatory requirements.
  • Support Quality Assurance in complaint handling, medical device reporting, vigilance reporting, field actions, and label approval.
  • Educate and train company employees on regulatory matters to assure compliance requirements.
  • Develop and maintain Material Safety Data Sheets (MSDS).

Key Qualifications:


  • BA/BS degree in a technical or scientific discipline. Advanced degree highly valued.
  • 10 plus years in QA with a minimum of 5 years experience in regulatory affairs.
  • At least 5 years experience with medical devices.
  • Ability to identify compliance risks, make decisions independently, and provide recommendations to management in resolving issues when necessary.
  • Demonstrated experience in validations, engineering documentation, Pre-Market Notification 510ks, and Pre-Market Approval (PMA).
  • Extensive FDA regulatory approval knowledge and experience interpreting regulatory guidelines.
  • Excellent organizational and communication skills with a high degree of attention to detail.
  • Possess strong leadership skills with team-oriented attitude and a collaborative style.
  • Strong research skills.
  • Proficiency in Word, Excel, Outlook and PowerPoint.

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