Technical Planning Associate

2 weeks ago


Stockholm, Stockholm, Sweden Intertek Full time

Key role: In the journey with the Medical Device Regulation (MDR), we need a Technical Planning Associate to bolster our Notified Body.

Responsibilities:

  • Guide projects for clients and ensure accurate technical planning activities.
  • Ensure compliance with ISO17021 Accreditation, EU Medical Device Regulation (EU) 2017/745, ISO13485, MDSAP, UKCA, UKAS, and other specific requirements.
  • Manage Change Management, contract revisions, technical inquiries, unannounced audits, and regulatory environment monitoring.
  • Liaise with clients, uphold confidentiality, deliver on promises, and address compliance issues promptly.
  • Support EUDAMED setup, comply with Quality Management System, and achieve assigned KPI objectives.

Requirements: Possess a relevant degree or equivalent experience in Health Science or Engineering. Experience in Quality Assurance and Regulatory disciplines within the Medical Device industry. Knowledge of EU Medical Device Directives, Regulations, and Quality Management Systems.

Personal skills: Detail-oriented, focused on delivering accurate results promptly, adept at coordinating and prioritizing tasks, and upholding professional integrity.

Location: Kista, Stockholm. Must be fluent in English and preferably Swedish.

Team: Report to the Technical Planning Team Leader and work with a team of 7 dedicated individuals.


If interested, submit your application with your resume promptly. This position may be filled before the last application date.

About us: Intertek is a leading service provider recognized for accuracy, reliability, integrity, and technical competence. Our services span various industries from textiles to medical devices. Join our team and collaborate with top professionals in the industry.


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