Regulatory and Compliance Manager – US – Chicago – 1293

1293 Regulatory and Compliance Manager US – Chicago

Our client is one of the world leaders in the design, development and manufacturing of drug delivery devices. They cover all types of business models: from full solution development to pure contract manufacturing, through customized solutions. The company puts the patient first and develop all their products with the end user in mind. They have a strong culture of innovation and have developed unique proprietary products.

This is a new position as the company develops more IP products that will report to a VP located in Europe (Germany) with frequent travel (60%) to Europe (6-7 times per year) and across the US.

The main objectives of the position are:

  • Support ICD teams with regards to all Pharmaceutical, Medical device, Facility registrational and other Regulatory aspects (Regulatory Matrix, contact with customer on Regulatory aspects)
  • Support Production plants for regulatory aspects such as submission of DMFs (Drug Master File), preparation of 3.2.P.7, Regulatory Support for customers etc.
  • Support and/or Submission of Premarket Notifications (510k) in the USA and follow up
  • Assess and provide regular updates of the relevant regulations for registration aspects
  • Maintain the Regulatory and Compliance section of the internal communication tool
  • Propose global strategies for submission of the company products to support the marketing team

The main responsibilities are:

  • Develop and lead Regulatory Strategies for selected IP products and specific Projects
  • Ensure compliance of plants to facility or product registrations
  • Development of skills and training of a regulatory team with a matrix organization
  • Review and approve regulatory submissions
  • Manage subcontracted activities with regards to submissions, registrations and compliance assessments

Candidate profile: 

  • 5 years of Regulatory Affairs experience in USA, dealing with medical devices (drug delivery or container closed systems)
  • Strong understanding of US regulations and FDA relationships related to drug delivery such as submissions of DMFs, preparation of 3.2.P.7 and regulatory support for customers
  • Bachelor’s Degree in chemistry, pharma or plastic engineering
  • Fluent in Englishwith excellent communication skills (verbal and written)
  • Attention to detail and accuracy
  • Ability to prioritize multiple projects concurrently
  • Able to take Initiatives and self-management
  • Excellent communication and teamwork skills within a Matrix Organization

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