Remote Devices and Combination Products Associate Program Director

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Tue, Jun 01, 2021

This job expires in: 11 days

Job Category: Program Management

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Masters

Job Summary

A biotechnology company is filling a position for a Remote Devices and Combination Products Associate Program Director.

Must be able to:

  • Help develop the Port Delivery System devices regulatory strategy
  • Build strong collaborations and relationships with internal stakeholders to ensure successful execution of regulatory submissions
  • Participate in creation and lifecycle management of device sections of IND/CTA and BLA/NDA/MAA, and technical files

Applicants must meet the following qualifications:

  • Applicants with a minimum of 5 years of experience in regulatory will be considered for Regulatory Program Manager
  • A minimum of 10 years of industry experience in regulatory and/or quality related field in the medical device industry
  • Knowledge of ISO guidance documents and health authority regulations/standards relevant to combination products or devices
  • Dynamic personality, ability to think outside the box and take smart risks
  • Curiosity and an ability to learn and deal with ambiguity within the organization
  • Effective problem solving and strong organizational skills, including ability to prioritize tasks

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