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LivaNova Deutschland GmbH
7d ago

Principal Regulatory Affairs Specialist(m/w/x)

München
Full-timeOn-siteExperienced

Description

You will guide medtech innovations through the regulatory landscape, from providing strategic input on development teams to managing complex submissions for global market clearance.

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Requirements

  • •BS in Engineering, Life Sciences, Pharmacy, Nursing, Mathematics, or Statistics
  • •Preferred graduate degrees in biomedical or clinical engineering
  • •Experience in regulated medical device industry
  • •Knowledge of pertinent regulatory submission regulations
  • •Understanding of clinical and regulatory principles
  • •Pragmatic and result-oriented mindset
  • •Independent technical writing project management skills
  • •Strong interpersonal and challenging skills
  • •Strong written and verbal English communication
  • •Strong technical writing skills for submissions
  • •Proficiency in MS Office
  • •Willingness to travel up to 25%

Education

Bachelor's degree
OR
Master's degree

Tasks

  • •Provide regulatory input for product development teams
  • •Develop submission applications for new or modified devices
  • •Participate in meetings with regulatory officials for market approval
  • •Interpret medical device regulations for senior management
  • •Respond to registration requests from regulatory authorities
  • •Review advertising and promotional literature
  • •Maintain regulatory files to ensure company compliance
  • •Implement initiatives to enhance operational efficiency and quality
  • •Develop and review quality system and clinical documentation
  • •Collaborate across departments to drive project best practices
  • •Ensure local regulatory requirements are met before distribution

Tools & Technologies

MS OfficeWordPower PointExcel

Languages

English – Business Fluent

Benefits

Competitive Pay

  • •Competitive base salary

Bonuses & Incentives

  • •Variable short-term incentives
  • •Variable long-term incentives

Informal Culture

  • •Supportive, inclusive, collaborative environment

Career Advancement

  • •Professional career growth

Modern Equipment

  • •Advanced Medical Device environment

Startup Environment

  • •State-of-the-Art development process

Other Benefits

  • •STARS Program recognition
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