Senior Regulatory Affairs Manager

LausanneFixeChimie, Pharma, Biotechnologie2019-05-09Bachelor / Collège / Diplôme
We are recruiting an experienced regulatory affairs specialist to manage new product development.

Senior Regulatory Affairs Manager

Your Responsibilities

Regulatory Affairs:
  • Collaborate with R&D and Sustaining team in the development of new and existing devices in the framework of the Informatics program for all regulatory activities (premarket). This activity includes development of regulatory requirements and strategies, preparation of documents etc.
  • Support of the team in charge of recordings devices worldwide as part of the informatic program.
  • Coordinates Post Market vigilance reporting and resulting actions for Informatics program.
  • Manage the maintenance of Technical Files such EC technical Files, 510(k) for Informatics program.
  • Support maintenance of Risk Management File with Risk Management Coordinator.
  • Participates during notified body audit and other inspections.
  • Establishes procedures for maintaining compliance with regulatory standards.

Human Factor:
  • Manage Human Factor Activities for all devices in collaboration with third party companies.
  • Act as an expert in Human Factor activities and support sustaining and new product development project to identify needs in terms of human factor requirements and activities.

Your Profile

  • Bachelor degree in Science or Engineering.
  • Minimum of 5 years' experience in Regulatory Affairs.
  • Minimum of 3 years' experience in Human Factor.
  • Minimum of 3 years' experience in Regulatory Affairs with software knowledge
IEC 62304, HIPPA, GDPR etc.).
  • Minimum of 5 years medical device industry experience including strong 510(k) submission experience, EU CE Mark submissions, Health Canada submissions, and international market submissions.
  • Strong working knowledge and experience with quality systems regulations and guidelines, ISO, GMP, Medical Device Directive (MDD) and FDA regulatory requirements.
  • Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
  • Demonstrated ability in project management skills in order to plan, conduct and implement system assessments and robust submissions.
  • Skill in determining alternatives that would correct a situation to comply with standards and regulations.
  • High level of planning and organizational skills desired.
  • Desire knowledge of medical terminology.
  • The environment is deadline sensitive. Frequent high-pressure situations.

Votre contact

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La référence de cette offre est JN -052019-295933