Mission

As Regulatory Affairs Specialist- Medical devices and machinery- you will contribute to the development of Trasis future products and support implementation of regulatory activities across business units, engaging with regulators and customers globally. The position is integrated into a fast growing company focused on continual improvement in a multi-cultural atmosphere, offering the ability to help lead and develop a new and growing regulatory specialty in radiopharmaceuticals. This position reports directly to the regulatory affairs manager.

Responsibilities

Examine current applicable regulations/directives and prioritize commercially driven markets to determine current and potential medium/ long term risks and impacts
Provide guidance to business units on the global regulatory landscape impacting medical devices and machinery to include monitoring of standards and ensuring the implementation of applicable standards and their compliance
Work at a strategic level to help build regulatory requirements into product development phase processes and educate on product related requirements
Manage post-market tasks related to registration and vigilance
Monitor scientific developments such as clinical trials and the competitive landscape
Advise and provide answers to questions raised internally, as well as questions from customers and government regulatory agencies
Support representation of Trasis interests in relevant working groups and trade associations
Represent Trasis regulatory at conferences as requested
Help to shape and develop the specific radiopharmacy regulatory landscape
Develop an external network

Qualifications

Bachelor degree in science, masters preferable with at least 2 years in regulatory affairs (medical device and machinery area preferred)
Fluent in written and spoken English. Other languages a plus
Experience communicating with regulatory authorities
Efficient project management skills, able to influence and educate others
Desire to work in a changing environment and contribute to building a new department
You are passionate about the radiopharmaceutical sector and have a strong interest in evaluating regulatory changes and challenges impacting the sector. Knowledge of the EU MDR and US FDA pathways essential
Ability to understand, translate, and communicate complex technical language into robust regulatory technical documentation with the support of R&D.
Innovation and operation oriented

Regulatory Affairs Specialist Devices

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