Regulatory Affairs Manager
In this role, you have the opportunity to
The Regulatory Manager is part of the Regulatory Affairs Team of the Innovation Site Eindhoven (ISE). In this position the Manager will be responsible for leading Medical Device development projects for the Mother & Child Care. The Regulatory manager is a strategic partner for the business groups. The activities will focus on the MCC Breastfeeding product portfolio.
o Take “Regulatory Ownership” of the Medical Devices, being the primary point of contact for the development teams.
o Involved early in Advanced Development Projects and Value Proposition Creation
o Involved in Clinical Claim Development
o Create Assessments of Medical Device Classifications for applicable Markets globally
o Create Regulatory Strategy Plan for medical devices projects part of the breastfeeding product portfolio
o Review Product Compliance Plans as created by Safety & Compliance Managers
o Review Product Labeling Plan
o Review Clinical Study Plan and Reports
o Create Regulatory Medical Device Submission Packages for markets like EU, U.S., Brazil, China
A dynamic and divers, team of highly specialized professionals with a common goal.
To succeed in this role, you should have the following skills and experience
o 10 years of experience in medical device regulations, in a commercial environment
o Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), Brazil (Anvisa) etc.
o Proven successful track record in regulatory submissions for medical devices
o Knowledge of Clinical Study setup, execution and reporting.
o Familiar with MDSAP and ISO 13485
o Knowledgeable on Product Risk Assessment strategies
o Strong Senior Personality being able to take position and guide a project team
o Knowledge of different standards for household and medical devices (e.g. electrical standards)