Spécialiste Affaires Règlementaire - Dispositifs Médicaux
- Employer
- NonStop Consulting
- Location
- Grenoble
- Salary
- Negotiable
- Closing date
- Oct 16, 2019
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Entry Level and Graduate
Job Details
- Processes regulatory requests in relation to product registration or tender requirements for the EMA region and provides responses in a timely manner. Where applicable, requests are to be made through the applicable (i.e. eGPS) system
- Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sales certificates and Certificates of Exportability. Interfaces hereto with applicable regulatory organization.
- Interfaces with OEM's to collect specific registration information as needed.
- Assembles technical information to create a "dossier" as needed.
- Maintains the EMA Registration databases
- Coordinates and supports the provision of a variety of statements to help the business
- Reviews and responds to internal and external customer requests for regulatory documents
- Follows up on all required translations for labels and IFUs.
- Develops and maintains departmental procedures (SOP's and work instructions) for international product registrations and/or regulatory activities as needed
- Has an understanding or desires to obtain knowledge of EU regulatory requirements for in vitro diagnostic medical devices products and medical devices
- Recognizes and proposes continuous process improvements.
- Manages small projects individually and provide support to other projects as appropriate.
- Provide other duties and assignments as required.
Your other skills include:
- Demonstrated self-starter, and highly motivated.
- Demonstrated analytical problem solving.
- Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
- Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
- Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; and effective interactions with technical personnel (scientific and legal).
- Orientation for detail work product, with emphasis on accuracy and completeness.
- Promotes a collaborative environment and removes obstacles to teamwork across the organization
- Ability to work in an international environment
- Travel: International travel up to 10%
- Education: Related degree level education required. Higher education is a plus.
- Licenses/Certifications: Industry/function specific certification preferred.
- Experience: 1-2 years or more related industry (e.g. life sciences) experience preferred.
- Competencies: Native level English proficiency, both written and verbal. Additional EU language is a plus. Computer literate.
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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