Regulatory Associate
About the Role:
You will be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations. This position requires an enthusiastic self-starter with a willingness to be a "hands-on" contributor.
The role involves:
* Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.
* Assist in the implementation of MDSAP within the organisation.
* Support the team to obtain / retain country-specific regulatory registrations on a global basis.
Main Responsibilities:
1. Provide strategic regulatory insight to team members regarding product development plans
2. Maintain the day-to-day activities of Post Market Surveillance, including logging customer complaints and adverse events.
3. Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
Requirements:
* Bachelor's degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.