Regulatory Affairs Specialist
il y a 4 semaines
Their EMEA HQ based in Brussels is looking to extend their team and sustain their growth within the Regulatory Affairs department. Job description As the successful Regulatory Affairs Specialist - Medtech, you will have the following responsibilities:
- Supports the organization to ensure an adequate and effective quality management system, supports the quality policy and sustains a quality culture.
- Maintain regulatory affairs files (e.g., registrations and CE-certificates, quality certificates, and device/facility licenses) and distribute information as required to support key stake-holders.
- Maintain an organized overview of applicable market authorizations and licences in the RA database.
- Develop and execute submission strategies to obtain clearance of international product registations in line with the applicable regulations.
- Ensure documentation meets EU MDR and other applicable regultions requirements to allow correct CE-certifications.
- Support and participate in audits performed by internal and external bodies.
- Support international sales and marketing with identification of regulatory registration requirements.
- Monitor regulatory developments and interpretation in EU by linking into available network through MedTech EU, EC commission resources, NB resources etc.
- Actively engage in development and implementation of regulatory projects.
- Follow-up, track and assemble regulatory commitments to Regulatory Agencies as required.
- Act as key interface and represent Avanos with local regulatory authorities and CE-certification agencies.
- Assist in preparation and execution of Field Action activities.
- Assist in the resolution of Quality Notifications and CAPAs as required.
- Minimum of 3 years of experience within Healthcare environment.
- University degree or related diploma.
- Experience with Excel, Word, PowerPoint and Outlook is required.
- Fluent in English.
- At least 3-5 years experience in Quality and/or Regulatory Affairs.
- RAC certification is a plus
- Ability to manage communication with regulatory authorities with a high level of professionalism
- Strong interpersonal skills and a positive attitude.
- Sound analytical skills (good attention to detail).
- Drive, energy and enthusiasm for meeting and exceeding expectations.
- Hands-on in a fast moving environment and able to work with little supervision.
- An attractive salary package - with all extra legal advantages (Insurances, Bonus, Net allowances, Meal Vouchers, etc.)
- Join a market leader - where people thrive to grow and learn
- Join a dynamic and fast growing team with growing responsibilities at the center of the business
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