Senior Manager, Regulatory & Quality Affairs, EMEA

France          ·       Full time

Job ID: 11161BR
Job Title: Senior Manager, Regulatory & Quality Affairs, EMEA
Location: France
432-France

Job Description

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.

Qualifications

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

Desired Qualifications

• ­Certification / membership in RA and/or Quality associations

Posting Country: Outside US

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