Regulatory Affairs Specialist

Excellent knowledge of EU regulatory medical device guidelines
- Previous global experience within the pharmaceutical/medical device industry within Regulatory Affairs
- Excellent written and verbal communication skills in English

To strengthen our RA team based in Paris, we are seeking a Global Regulatory Affairs Specialist.

This role is full time, permanent, with approximately 30% travel.

The Global Regulatory Affairs Specialist will support global regulatory affairs across +80 territories.

Tasks may include but are not limited to:

- Coordinate with the RA Director, our company QA team and Commercial teams to plan, organize, record progress, and submit regulatory submissions to national Health Authorities on a timely basis
- Address regulatory queries from notifying bodies, Health Authorities and distributors and maintain regulatory approvals
- Ensure that all regulatory dossiers are maintained and updated to the highest professional standards, ensuring that our company confirms to all legal and ethical requirements in the country.
- Ensure proper document retention / archiving of all Regulatory documents.
- Update Global Database and RAMS directory with any new / changed information to ensure that information is current.
- Support and at time lead the annual Regulatory Intelligence Exercise
- Liaise with Regulatory Affairs and Commercial to plan registration, renewal and variation activities around the strategies that have been chosen as part of the strategic planning and business plan exercises.
- Responsible for the regulatory landscape assessment and meet with local stakeholders to support the registration activities in the our company's countries. - Accountable for the compilation, regulatory accuracy, and completeness, of the documentation required by the Regulatory Authorities.
- Prepare and follow up product dossiers as per country guidelines as necessary to obtain and sustain product approval in designated territories
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents, and maintain regulatory intelligence database, including overall responsibility for the RAMS tracker software and MVA tracking spreadsheet
- Review and make recommendations and liaise with our company QA team on all relevant documentation such as ‘product labels’ and ‘instructions for use’ to ensure compliance with EU & countryspecific requirements
- Effectively communicate the status of submissions with the Director of Regulatory Affairs, and Commercial and Marketing teams.
- To ensure that all product labelling complies with the Regulatory Authorities’ requirements and internal SOPs where products are marketed
- Foster professional working relationships with internal and external contacts; WomanCare Local Technical Representatives (LTRs) and distributors at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
- Support QA team as and when required to maintain QMS and participate in weekly RA/QA calls
- Act as EU RP for MVA - Within the scope of medical regulation MDR 2017/745, ensure an effective implementation of the post-marketing surveillance system to collect, record, analyze all relevant data related to safety and performance.

The post-market surveillance is conducted according to the risk classification and type of medical device, and is carried out throughout the lifetime of the device

Profil recherché
Professional integrity and strong ethics are assumed.
- Clearly, proven organizational management skills are essential attributes
- Strong planning, strategizing, managing, monitoring, scheduling, and critical thinking skills
- Excellent written and verbal communication skills in English to clearly and concisely present information.
- Strong interpersonal skills in a fast-paced, deadline oriented and changing the environment
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
- Ability to work and exercise sound judgment and make decisions independently
- Excellent self-motivation skills
- Excellent knowledge of EU regulatory medical device guidelines
- Bachelor's Degree in Chemistry or Life Sciences or relevant regulatory qualifications such as RAPS.
- Previous experience within the pharmaceutical/medical device industry within Regulatory Affairs
- English, French Fluent, additional languages skills such as Spanish or any other internationally spoken languages are a plus) as well as Arabic and or Portuguese

Télétravail
Mutuelle d'entreprise
Tickets restaurant
Our company is currently and until further notice, working in hybrid mode combining both remote and office work.