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
- 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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