What are the responsibilities and job description for the Regulatory Affairs position at ComTec?
Position: Regulatory Affairs / IVDR International registration
Location: Newark, DE - 19702
Duration: 12 Months
Description:
3-5 years of experience analyzes the requirements and prepares product related regulatory submissions.
* Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
* Identifies, analyzes and implements country specific requirements necessary for product related submissions.
* Plans and prepares product related submissions with internal (e.g. Regional Units) or external organizations according to regulatory requirements.
* Performs regulatory projects or acts as a member of the project steering group.
* Submits required documentation/information to local authorities.
* Initiates and escalates necessary activities if deviations are identified.
* Ensures creation of adequate documentation for audits/inspections.
* Performs training within the organization in country specific regulatory requirements, if applicable.
* Performs review of promotional material for regulatory compliance according to country specific requirements.
* May represent the company in industry associations (Lobbying), if applicable.
Job Types: Full-time, Contract
Salary: $32.00 - $33.50 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Newark, DE: Reliably commute or planning to relocate before starting work (Required)
Experience:
- regulatory compliance: 5 years (Required)
Work Location: One location
