Regulatory Affairs Custom Device Team Lead / Senior Regulatory Affairs Custom Device Associate
Main Purpose of Job and Objectives:
* Perform Regulatory tasks to ensure compliance with regulations.
* Prepare regulatory documentation and submissions for product approvals.
* Develop regulatory plans/strategies for new products and changes to existing products.
* Participate in Design Control and Risk Management activities.
* Review and prepare regulatory paperwork in accordance with international standards and regulations.
* Review product packaging, labelling, IFUs, and marketing literature for compliance.
* Facilitate compliance with Vigilance System.
* Provide regulatory input to functional groups.
* Participate in the review of RA procedures.
* Review and approve validation protocols and reports.
* Mentor RA Associates.
* Facilitate in the compilation, communication, and monitoring of FSN and recalls.
* Perform other duties as required by the RA department.
Dimensions & Limits of Authority:
* Must work within the requirements of the company handbook and policy statements.
* Maintain awareness of the relevance and importance of activities performed and how they contribute to quality objectives.
* Ensure accurate completion of records and report any quality issues to the immediate supervisor.
* Ensure facility, processes, and documentation remain in a state of audit readiness.
Qualifications & Experience:
* Experience in team/project management/custom-made devices is desired.
* Experience with quality engineering and/or MDR is required.
* Able to communicate effectively with external parties such as customers and distributors.
* Able to communicate effectively with personnel in QA/R&D and other departments.
Company Requirements:
* Must adhere to the company handbook and policy statements.
Quality Requirements:
* Maintain awareness of how activities contribute to quality objectives.
* Work within the Quality Management System at all times.
* Ensure accurate completion of records and report any quality issues to the immediate supervisor.
* Ensure facility, processes, and documentation remain in a state of audit readiness.
EH&S Requirements:
* Take care of your own health and safety and that of others who may be affected by your actions.
* Work cooperatively to highlight issues affecting Health and Safety.