MicroVention Jobs

12195BR

Title:

Specialist Quality & Regulatory Affairs, EMEA

Job Description:

Assist in maintaining a sustainable Quality Management System and oversight Regulatory Affairs for EMEA countries.

Will act as PRRC deputy (Person Responsible for Regulatory Compliance) for reporting obligation for MicroVention (MVE) and vigilance officer deputy (ANSM).

1. Quality

• Support the QA/RA Director in maintaining a QMS that meets the applicable regulatory and company requirements including ISO 13485/EU regulations

• Perform internal audits

• Assist in the creation of standard operating procedures and work instructions for MVE if needed

• Support the Sr QA/RA Manager with post-market regulatory compliance / surveillance activities for EU

• Assist with customer complaints

• Manage Customer Response Letters

• Assist with regulatory issues such as recalls or field safety corrective actions and advisory notices

• Work cross functionally with other departments to achieve goals

2. Regulatory

• Coordinate the process and review of documents for advertising and promotional material based on local regulations

• Prepare the product info and “fiche europharmat” for business purposes

• Review vigilance reports

• Update RA SharePoint to ensure latest version of RA documents are available for international registrations (international registration will continue to be managed by CS and RA support position)

• Help transition locally from MDD to MDR

3. EU MDR

• PRRC deputy role for reporting obligations: when MVE is legal manufacturer, will be responsible for ensuring that the reporting obligations related to vigilance, trend reporting, and FSCA are fulfilled

• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization

• Perform additional duties as assiged

Auto req ID:

12195BR

Location:

France

Department Name:

432-France

Qualifications:

Required Qualifications

• Certification / membership in RA and/or Quality associations

• Experience with ISO 13485, ISO 9001, and EC certification

• Experience in international medical device company

• Auditing skills

• Strong team player providing support, guidance, and expertise in achieving regulatory compliance and customer satisfaction by educating, analyzing, and facilitating improvements through interaction with both internal and external customers

• Strong written and verbal communication skills, including advanced English and French language proficiency

• Hands-on, constructive, and forward-looking attitude

• Attention to detail; good organization and planning skills

• Demonstrated ability to meet deadlines

• Autonomous, strong capacity to take initiative and responsibility for action

• Knowledge of EU regulations and standards, such as (but not limited to) MDD, EN ISO13485

• A minimum of three (3) years of relevant experience in Quality System / Regulatory Affairs function

• A minimum of five (5) years of work experience at a medical device company

Desired Qualifications :

Internal Auditor to ISO 13485:9001 desired

External-Facing Title:

Specialist Quality & Regulatory Affairs, EMEA

Posting Country:

Outside US

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.