Regulatory Affairs Manager

Job description

     

JOB DESCRIPTION:

Abbott is recruiting a Regulatory Affairs Manager to be based in Paris, France.

Your responsibilities include:

·  Review and approval of advertising and promotional materials in France.
·  Preparation and submission to the French Competent Authorities all advertising and promotional materials requiring a prior approval from ANSM per the local regulatory requirements.
·  Notification of placing on the market of new products in France to ANSM.
·  Maintenance of existing notifications, and management of changes to existing notifications, in relation to the new European Medical Device Regulation.
·  Notification to the French competent authorities of new reimbursed products (LPPR declaration)
·  Declaration to the French competent authority of the Economic Operator activity (Affiliate as Distributor)
·  Provide regulatory support to the French Commercial team on tenders and field requests (from sales team, marketing team and reimbursement team): CE certificates, IFU, labels, ISO and EU MDR questions
·  Provide local support and responses to technical queries, e.g. MRI compatibility, latex/PVC content.
·  Support and respond to GDPR questions as appropriate.
·  Support and respond to Privacy Shield questions as appropriate.
·  Provide regulatory affairs support and input to internal and external audits.
·  Provide regulatory training to employees.

Your Profile:

·  BA or BS degree (degree in a technical or science discipline highly preferred).
·  Knowledge of EU medical device regulations and Quality Management Systems for medical devices.
·  3-5 years relevant experience within regulatory function in medical devices industry and knowledge of regulatory requirements in France and Europe (CE marking)
·  Ability to work in a highly matrixed and geographically diverse business environment.
·  Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
·  Multitasks, prioritizes and meets deadlines in timely manner.
·  Strong organizational and follow-up skills, as well as attention to detail.
·  Fluency in French and English
·  Strong analytical skills
·  Customer oriented attitude with strong communication skills
·  Attention to detail and accuracy is required.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

France > Issy les Moulineaux : 3 esplanade du Foncet

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable