Regulatory Affairs Specialist

4 days ago

New York, New York, United States Allentown LLC Full time
Job Title: Regulatory Affairs, Quality & Compliance Leader

We are seeking a highly experienced and skilled Regulatory Affairs, Quality & Compliance Leader to join our team at Allentown LLC. As a key member of our organization, you will be responsible for leading our regulatory strategy and ensuring compliance with FDA, EU, and other international regulations.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with FDA, EU, and other international regulations.
  • Lead the formulation and execution of the company's regulatory strategy, including preparation of documents and submissions required to obtain clearance or approval from government agencies.
  • Build and maintain relationships with key regulatory bodies, including the FDA and EU Notified Bodies.
  • Develop and maintain internal quality and compliance documents, systems, and processes.
  • Provide regulatory consultation to other internal and external stakeholders.
  • Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries.
  • Maintain up-to-date knowledge of Federal USA, Canadian, MDR, and other international regulations, policies, and guidance pertaining to medical device sterilization.
  • Oversee processes involved with maintaining annual licenses, registrations, and device listings.
  • Pursue government grants and environmental accreditations.
  • Assist with the development and publishing of peer-reviewed articles to highlight our technology and equivalence/differentiators vs. other sterilization modalities.
Requirements:
  • Bachelor's degree in science (biology, microbiology, chemistry), engineering, or other relevant focus area; Master's degree or PhD preferred.
  • 10-15 years of experience in an FDA-regulated industry, including experience writing 510(k) or PMA submissions in the last 5 years.
  • Experience in a medical device regulatory/quality assurance environment preferred.
  • Experience with the sterilization aspects of 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred.
  • Certifications are a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Supervisory or management experience preferred.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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