Senior Manager, Regulatory & Quality Affairs, EMEA

Position Overview

Responsible for MicroVention Europe Quality System and Regulatory Affairs functions. Job duties:

Regulatory Affairs
  • ­Responsible for regulatory communications with French Competent Authority (ANSM):
    • Assigned as a Vigilance Correspondent for reportable events in EU.
    • Notifies ANSM about new CE marked products placed on the market.
    • Submits vigilance reports to Competent Authorities, as requested by management.
  • Support to corporate registration and local coordination of communication to EMEA distributors as assigned by Corporate RA department.
  • Stay current on EMEA regulations changes and timely inform Corporate Regulatory Departments about these changes.
Quality Systems
  • ­Implement, maintain, and/or improve the quality system to meet regulatory compliance requirements in MicroVention Europe as part of corporate quality system.
    • Participate in regulatory inspections and notified body audits.
    • Write and updates Quality Procedures.
    • Support and provides input into Corporate Management Review.
    • Support the Complaints process and activities as required by corporate procedures and Corporate Field Assurance.
    • Facilitate and support CAPA, manages CAPA initiated in MicroVention Europe.
    • Participate in Internal Audit program and conducts internal audits as requested by Corporate.
  • Maintain current knowledge of cGMP/QSR, ISO, and other related regulations and conducts training as appropriate.
  • Work cross-functionally with other departments to achieve company and departmental goals.
  • Ensure that MicroVention Europe quality processes are compliant with corporate procedures as well as with standards and regulations.
  • Provide input and supports Field Actions initiated by Corporate.
  • Recommend and implement process changes as needed.
  • Assist in the development and responsible for the administration of the Employee Training Program, including GMP-related training of the MicroVention Europe including orientation of new regular and temporary personnel.
  • Propose, implement, and enforce quality improvements in MicroVention Europe to support corporate Quality Policy.
  • Work closely with sales team to improve customer relationships and customer service.
  • Perform additional duties as assigned.

Job Details

    1. Technical or Life Science degree (BS).
    2. Strong English language skills.
    3. Solid knowledge of EU regulations and standards, such as (but not limited to) MDD, EN ISO 13485, and international regulatory requirements.
    4. Attention to detail, good organizational and planning skills.
    5. Demonstrated ability to meet deadlines.
    6. Solid verbal and written communication skills.
    7. Minimum five (5) years in Quality System / Regulatory Affairs functions.
    8. Minimum five (5) years working in a medical device company.
    9. Minimum three (3) years of management experience.
    Desired Qualifications
    1. ­Certification / membership in RA and/or Quality associations