One of the biggest pharmaceutical companies in the world is looking for a Medical Regulatory Affairs Specialist on a Freelance base. You will be on a one-year project with possible extension. The company is in Beerse (Belgium).
- AR agreement maintenance
- Verification of Manufacturer’s compliance for new MDR products certification incl. lifecycle, change and record management etc.
- Completes verification measures per process
- Verifies data
- Notifies Manufacturer about gaps / required corrections and completes verificationonce addressed by Manufacturer
- Registration of AR (Eudamed) incl. lifecycle management
- Initiates and maintains registration measures per procedures
- Actor (AR) registration in Eudamed
- May act as Deputy LAA
- Shares Single Registration Number (SRN) with manufacturer within designated
timelines and with other EOs upon request
- Upon notification of potential actor registration gaps or errors, corrects within relevant systems in designated timelines
- Manages AR registration related fees and invoices if applicable
- Supports the verification of Manufacturer’s device data registrations (Eudamed) incl. lifecycle, change and record management etc.
- Provides regulatory and quality support to the Supply Chain End to End EU MDR Pilot Process
- Address Economic Operators requests (DELIVER Quality) during the hyper care period including support and training to access relevant documents, address question and liaising with the manufacturer to ensure resolutions on Nonconformities escalated by the DELIVER Quality Organization.
- Coordinates Competent Authority (CA) requests incl. NC/CAPA, FSCA related
- Supports CA Inspections and internal and external audits
- Maintains Procedures, Work Instructions and Job Aids relevant to AR processes (including but not limited to AR, EUDAMED, EoV)
- Creates and approve ECOs pertaining to the coordinator’s projects and duties (including but not limited to SOPs)
- Provides operational support for economic operator and AR initiatives for CSS, including but not limited to AR Council Meetings
- Performs other duties, per AR SOP 100674766
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- A university degree or equivalent in Science, Engineering, Technical or Biomedical field or Law.
- 2-4 years – experience in Regulatory Affairs or Quality Affairs preferred
- Working knowledge of medical device regulatory requirements in the EU, Quality Management Systems and experience in the Medical Device industry or medical field is a pré
- Ability to proactively identify new ideas and solutions
- Ability to gather information, plan and execute objectives
- Project management skills with strong results orientation
- Teamwork and leadership skills
- Strong communication, influencing and presentation skills
- Ability to effectively communicate to top management
- Ability to perform duties in accordance with policies and procedures
- Excellent written and verbal communications skills in English (required) and one other EU language (desired)
ORGANISATION AND OFER
You will join growing and innovative organization and will be involved in successful projects with customers all over the world. You are part of a multi-disciplinary team that is continuously creating value for their clients.
This is a unique opportunity to develop yourself and to grow within the company. You can expect an attractive salary and benefits.
INTERESTED? Reach out to Sayf Idais for more information by contacting +31 (0)20 20 44 502 or email@example.com