Regulatory Affairs Specialist
+32 494 04 21 32
The RA Specialist supports the tasks of the Senior RA Executive Manager and Senior RA Manager, who are accountable for the regulatory process of the product lifecycle as well as during development. Under the supervision of the Senior RA Executive manager, the RA Specialist supports the interactions with the product life cycle management, the development process, the supply chain, internal teams, external customers, and a variety of regulatory bodies.
The main requirements for this position are the following:
- Prepare documentation for regulatory submissions (both drug products and medical devices)
- Perform updates of the Technical Documentations
- Update the tracking systems within the Regulatory department
- Maintain quality related files and records ensuring traceability in accordance with the appropriate procedures
- Assess the regulatory impact of change controls.
- Act as a team member to represent regulatory affairs on assigned product and project teams
- Assist the investigation and evaluation of regulatory history, guidelines, policies and regulation specific to products and markets.
- Support written and verbal communication with customers and regulatory bodies
- Minimum of Master in Physics, Chemistry, Biology, Pharmacist or a Bachelor in Sciences with relevant experiences
- 3-5 years related experience in medical device and/or pharmaceutical industry
- ISO13485,GMP, GDP, MDD, MDR or ICH Q, EMA/CHMP knowledge is an advantage
- Fluent in English (Spoken and written)
- Proficiency with MS Office (Excel, Word, PowerPoint & Outlook)
- High regard for attention to detail
- Excellent Time Management skills
- Team player