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
