RA Specialist

Location Amersfoort
Discipline: Biotechnology, Pharmaceutical, Medical Device
Job type: Temporary/Freelance
Contact name: Selin Ozbeden

Contact email: s.ozbeden@panda-int.com
Job ref: 12301
Published: 23 days ago

Urgently looking for a Regulatory Affairs Specialist for a leading biotech company with the ability to analyze, interpret and synthesize regulation and guideline. Also who will identify regulatory issues, risks and priorities, and manage them.

RESPONSIBILITIES

  • Label and Instruction for Use – review and approval, and the management thereof.
  • Update of RA database.
  • Handle all necessary activities for the release of SKU (codes) restrictions.
  • Local Management of the MV Project and related communication to all stakeholders.
  • Ensure regulatory compliance of Medical Devices (MD) for their access to the market of Belgium, Netherlands and Luxembourg.
  • Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, report them to the relevant RA Leaders (at global and local level), investigate and suggest solutions to resolve them.
  • Support for One MD Organizations in Netherlands and Belgium related to the Project.
  • Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs, and act as the main contact person for any natters related to the Project impact issues.
  • Collaborate with local Commercial, Marketing, Tendering, Finance & Supply Chain teams, to ensure flawless completion of the Project and related activities, and accurate and timely reply to stakeholder requests.

PROFILE
Language requirement: Excellent in English and Dutch (write, read and speak)
Advanced level in Excel (mandatory & non-negotiable)
Analytical, self-motivated, energetic and self-disciplined person
Problem solver
Fast learner
Good communication skills
Attention to detail
Able to work in a high-paced environment
Other features of the job:
Knowledge of EU Medical Device requirements will be beneficial
Previous experience in Medical Devices or Pharma industry will be beneficial

JOB REQUIREMENTS

  • Essential knowledge and skills:
  • Education Level: Junior scientist (Pharmacist, Engineer, Biologist, Chemist, etc.)
  • Ability to build partnerships internally and externally
  • Advanced level in Excel (mandatory & non-negotiable)
  • Ability to analyze, interpret and synthesize regulation and guidelines
  • Ability to identify regulatory issues, risks and priorities, and manage them
  • Consistent skills to work in parallel environments (business and regulation), to provide feedback and background of regulation update and its impact on RA strategy.
  • Rigorous and well organized
  • Capability of self-awareness and adaptability

START DATE

  • June 15

DURATION

  • 6 months

INTERESTED?

If you’re interested in the above description, please apply with your CV. For further information, please contact Selin Ozbeden at   +31 (0)20 20 44 502 or by email at s.ozbeden@panda-int.com