Ready for a new challenge working on global regulatory activities for an interesting portfolio of medical devices? This role has a bit of everything, transition to MDR, support to new product development and more!
Enjoy a great work life balance, challenging regulatory markets and an excellent team enviroment in this regulatory affairs manager position. Sitting in the company headquarters, you will be in the midst of all the new product development, have the opportunity to work on bringing new devices to market, and lead regulatory projects.
Your opportunity as regulatory manager:
Manage a porfolio of challenging software/hardware medical devices globally
Drive the regulatory vision for your portfolio in New Product Development Projects
Develop the company's regulatory presence in existing key markets (EMEA, USA) through CE marking, 510k submissions and agency interactions
Extend your RA knowledge in up and coming challenging new markets such as Brazil and China
Guide regulatory approval processes from "cradle to grave"; concept to clearance
Prepare regulatory submissions, maintain existing registrations and provide regulatory intelligence on competitor regulatory strategy
Advise key stakeholders on the regulatory strategy for new product launch
Maintain awareness of changing MDD regulations and guidelines, and communicate their impact on existing and future product registrations
Desired Skills and Experience
2-5 years experience in Regulatory Affairs pre market functions for medical devices class IIa, or IIb, or III
Proven regulatory experience with medical devices
Experienced in dealing with Regulatory Affairs in at least EMEA