Corin are currently seeking a Regulatory Affairs Specialist to support the Regulatory Affairs Manager to participate in registering products, the implementation of the MDR (Medical Device Regulation), and the Authorised Representative/distributor activity. The job opportunity is based in Montbonnot (38), France, full time (CDI).
Main Purpose of the Regulatory Affairs Specialist are to;
- Actively participate in products registration
- Participate to the implementation of the MDR
- Participate to the authorised representative/distributor activity
- Provide efficient contribution to regulatory intelligence
- Promote a culture centred on regulatory compliance among company staff
The Regulatory Affairs Specialist key responsibilities are to:
Actively participate in products registration so that they can be marketed according to the defined schedule:
- Prepare and update the regulatory design dossier/technical file with which s/he is entrusted,
- by collecting the information needed to prepare registration files and check they comply with regulatory requirements
- by drafting the file application using the information collected and by answering any questions concerning the files raised by the competent authorities
Participate to the implementation of the MDR:
- Prepare and update the regulatory design dossier/technical file to be compliant to the MDR.
- Create/update the SOP to be compliant to the MDR
Participate to the Authorised Representative/distributor activity:
- By collecting and checking the evidence required to be the authorised representative / distributor of devices for Corin Group.
Provide efficient contribution to regulatory intelligence:
- By reading regulatory information on literature/websites dedicated to regulatory environment
- By analysing and providing summaries of articles concerning the company’s sector of activity and by providing the persons concerned with regulatory information
- Present the regulatory requirements with which the company must comply at meetings taking place during the development of new products, when products are changed or when the sale of products is to be extended to new markets
Promote a culture centred on regulatory compliance among company staff:
The ideal Regulatory Affairs Specialist will have:
- A Scientific or technical training (up to Master’s degree or equivalent), Medical Device Master
- Knowledge of quality standards and regulations in the medical device field (European directive, MDR, ISO13485)
- Good English skills (writing, reading and speaking). 90% of the job is in English.
- Have a disciplined and organized approach to preparing and monitoring files
- Be practical and efficient
- Be autonomous, thorough and persevering
- Be able to analyse and summarize
- First experience expected: Preparing device registration files, in the medical device environment
- Show good interpersonal skills in relations with co-workers (project group, other departments for the preparation of registration files) and people outside the company (auditors, inspectors, subsidiaries, distributors)
- Good command of computer tools (Word, Excel, use of internet, etc.)