Regulatory compliance specialist

3 weeks ago

Birmingham, United Kingdom Meet Full time

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.

  • Regulatory Compliance Specialist

    1 month ago

    Birmingham, United Kingdom Meet Full time

    Regulatory Affairs Custom Device Team Lead / Senior Regulatory Affairs Custom Device AssociateMain 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...

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