Position Overview
As Regulatory Support Specialist you will support Product Managers, Regions, and customers by providing quality documents and regulatory support for bioprocess products. You will add value by ensuring customer satisfaction.
Responsibilities
- Build and maintain knowledge of customers’ regulatory requirements related to the bioprocess business at a high level.
- Develop and update regulatory support documentation for products in customers’ regulated environments.
- Perform investigations and prepare and deliver statements and certificates.
- Participate in creating and updating guidelines and steering documents.
- Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions.
- Participate in project teams as regulatory support expert.
- Respond efficiently and promptly to customers’ regulatory issues, including necessary investigations, preparations and delivery o...