Log In
Sign Up
Responsibilities:
- Lead the preparation of submissions and documentation.
- Serve as regulatory lead on CDx project teams.
- Represent Precision in meetings with regulatory agencies.
- Design strategic approaches to regulatory approvals.
- Review and direct development of protocols and reports.
- Stay abreast of latest regulatory developments globally.
- Perform regulatory impact assessments for changes.
Requirements:
- BS Degree in Sciences or similar discipline.
- Minimum 5+ years of regulatory experience.
- Knowledge of global IVD regulations.
- Strong written and verbal communication skills.
- Ability to prioritize tasks and meet deadlines.
- Strong scientific and analytical skills.
Benefits:
- Compensation range: $95,000 – $113,000 USD.
- Discretionary annual bonus.
- Health insurance and retirement savings benefits.
- Life insurance and disability benefits.
- Parental leave and paid time off for sick leave.
