Regulatory Affairs Manager or Quality Assurance Manager

Employbridge•Ventura, CA

3d•Onsite

About The Position

Job Description Essential Functions: 1.Prepare regulatory submissions/registrations/licensing documentation. 2.Ensure that processes needed for regulatory compliance are established, implemented and maintained, and continuously improved. 3.Supervise and coordinate all positions related to Regulatory Affairs. 4.Evaluate product and product concepts for compliance with the appropriate governing regulatory requirements. 5.Evaluate international authorized distributors. 6.Monitor company for compliance with Regulatory Standards and the Quality Management System (QMS). 7.Interface, as the primary contact, with State, Federal and International Agencies (Management Representative). Primary lead (host) for regulatory and notified body/ISO Registrar audits. 8.Interface, as the primary contact, with Notified Body/ISO Registrar and applicable foreign distributor regulatory departments regarding applicable product issues, product changes or quality system changes. 9.Monitor and report to top management the applicable regulatory requirements. I 0. Advise on regulatory issues. Ensure the promotion of regulatory requirements throughout the organization. Provide regulatory guidance to departments and communicate regulatory information and ensure that the information is interpreted correctly. 11.Plans, prepares and conducts Management Review meetings. 12.Responsible for regulatory issues 13.Perform regulatory documentation review 14.Plan and implement QMS and applicable regulatory training. 15.Manage (implement, maintain and continuously improve) the internal audit system. 16.Manage (implement, maintain and continuously improve) the customer Complaints/Feedback System. 17.Manage (implement, maintain and continuously improve) the regulatory adverse event reporting system. 18.Manage (implement, maintain and continuously improve) the product recall and advisory notice systems. 19.Manage (implement, maintain and continuously improve) clinical evaluations. 20.Plans, schedules, and follows up on QMS audits (external & internal and regulatory). 21.Support OEM customer audits. 22.Clarify, define and defend regulatory policy. 23.Supervise employees making decisions regarding hiring, firing, discipline and performance evaluations. 24.Communicate with coworkers at all levels 25.Required to be present in the work place during scheduled work hours. 26.Ability to work independently to perform daily operating tasks.

Responsibilities

Prepare regulatory submissions/registrations/licensing documentation.
Ensure that processes needed for regulatory compliance are established, implemented and maintained, and continuously improved.
Supervise and coordinate all positions related to Regulatory Affairs.
Evaluate product and product concepts for compliance with the appropriate governing regulatory requirements.
Evaluate international authorized distributors.
Monitor company for compliance with Regulatory Standards and the Quality Management System (QMS).
Interface, as the primary contact, with State, Federal and International Agencies (Management Representative). Primary lead (host) for regulatory and notified body/ISO Registrar audits.
Interface, as the primary contact, with Notified Body/ISO Registrar and applicable foreign distributor regulatory departments regarding applicable product issues, product changes or quality system changes.
Monitor and report to top management the applicable regulatory requirements.
Advise on regulatory issues. Ensure the promotion of regulatory requirements throughout the organization. Provide regulatory guidance to departments and communicate regulatory information and ensure that the information is interpreted correctly.
Plans, prepares and conducts Management Review meetings.
Responsible for regulatory issues
Perform regulatory documentation review
Plan and implement QMS and applicable regulatory training.
Manage (implement, maintain and continuously improve) the internal audit system.
Manage (implement, maintain and continuously improve) the customer Complaints/Feedback System.
Manage (implement, maintain and continuously improve) the regulatory adverse event reporting system.
Manage (implement, maintain and continuously improve) the product recall and advisory notice systems.
Manage (implement, maintain and continuously improve) clinical evaluations.
Plans, schedules, and follows up on QMS audits (external & internal and regulatory).
Support OEM customer audits.
Clarify, define and defend regulatory policy.
Supervise employees making decisions regarding hiring, firing, discipline and performance evaluations.
Communicate with coworkers at all levels
Required to be present in the work place during scheduled work hours.
Ability to work independently to perform daily operating tasks.