Sr. Regulatory Affairs Associate.

Position Overview.

The Senior Regulatory Affairs Associate is responsible for working with domestic and international regulatory agencies and internal personnel to obtain and maintain product approvals and uphold regulatory compliance. The Senior Regulatory Affairs Associate will participate in all phases of the device lifecycle, from design, development, and device approval to post-market surveillance.

This position reports to the Regulatory Affairs Manager.

 

Essential Duties & Responsibilities

  • Support to develop regulatory strategies to ensure applicable global requirements are met.
  • Support the preparation of timely and compliant submissions to domestic and international regulatory agencies (510(k), IDE, PMA, HDE, IND, BLA, CE dossiers, supplements, responses, state licensure/certifications, export certifications, product registrations, etc.).
  • Support the Completion of regulatory assessments of product modifications and ascertain impact on current regulatory approvals.
  • Support activities to implement and maintain EU MDR 2017/745 and UK MDR requirements.
  • Interpret regulations and related information for Research & Development, Operations, Quality Assurance, and Marketing.
  • Evaluate and recommend changes to labeling, marketing literature, and clinical protocols for regulatory compliance to recognized laws or regulations.
    Communication with responsible regulatory authorities and distributors (domestic/international).
  • Support the Clinical Evaluation procedure updates to comply with the EU MDR 2017/745 and UK MDR requirements.
  • Complete Technical Gap Assessments as required.
  • Have experience with Technical writing of the documents.
  • Support the interaction with regulatory agencies as part of submission review and on-site audit support.
  • Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity relating to products, processes, and the quality system as applicable to the responsibilities outlined with this job description.
  • Develop, review, and support maintenance of regulatory SOPs.
  • Collaborate with cross-functional teams.

Education

Minimum Bachelor’s degree in a scientific discipline

Experience and Skills

Work Experience Required:

  • Minimum of 5 years’ experience in medical device Regulatory Affairs
  • Preferred experience – involvement in at least one combination product submission

Specialized Skills, Knowledge:

  • Excellent written and oral communication skills
  • Ability to write documents for regulatory submission
  • Experience in preparation of U.S. submissions and Design Dossier applications
    Proficient in pertinent software & tools
  • Strategic-minded, analytical and detail-oriented
  • Ability to work independently and as part of a team

Certification Requirements:

  • RAC certification preferred

Physical Requirements

The physical demands of this position are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

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