Regulatory Affairs Specialist
il y a 1 semaine
Corin is 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).
**The purpose of the Regulatory Affairs Specialist**:
- Participate to the authorized representative/Importer/distributor activity
- Provide efficient contributions to regulatory & standard intelligence
- Actively participate in product registration with the French and foreign authorities (MDR, 510k)
- Promote a culture centred on regulatory compliance among company staff
The key responsibilities of the Regulatory Affairs Specialist are;
Participate in the Authorised Representative/ Importer distributor activity:
- Carry out activities pertaining to Corin France's role as European Representative and/or importer and/or distributor of medical devices in the European Union
- Perform checking activities of information and documents provided by the manufacturer and confirm compliance of the devices with the applicable regulations, with the approval of the Regulatory Affairs Manager
- Analyse changes notified by the manufacturer and the impact on existing documents and device compliance
- Assist in communications with the manufacturer, Competent Authority, or Notified Body and prepare response and documentation as requested by authorities,
- Assist in Eudamed registration and updates
Provide efficient contributions to regulatory & standard intelligence:
- By performing the regulatory & standard intelligence
- By analyzing and providing summaries of articles concerning the company’s sector of activity and by providing the persons concerned with regulatory information
Actively participate in product registration with the French and foreign authorities (MDR, 510k) with a view to bringing them to market in accordance with the defined schedule:
- Represent the regulatory department in the project groups where s/he is appointed
- Draft and update the documents s/he is in charge of
- Prepare and update the technical product registration files with which s/he is entrusted,
- by collecting the information needed to prepare registration files and check they comply with regulatory requirements
- Prepare and make available the documents required to sell medical devices:
- administrative documents (technical data sheets, marketing authorization documents
- 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
Promote a culture centered on regulatory compliance among company staff:
- 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
We are looking for a Regulatory Affairs Specialist who
- 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, 21CFR )
- Good English skills (writing, reading, and speaking). 95% 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 analyze 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 the internet, etc.)
Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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