Key Role: Regulatory Compliance Specialist
This is an exciting opportunity to contribute to a company that has developed a breakthrough medical device addressing pain points in the surgical tympanostomy procedure.
About The Position:
We are seeking a highly skilled Senior Regulatory Specialist to ensure compliance with all relevant regulations and standards. As part of our cross-functional team, you will facilitate regulatory approval processes, collaborate with colleagues, and provide strategic guidance on regulatory matters.
Responsibilities:
* Develop and execute regulatory strategies for product registration, approval, and compliance.
* Manage day-to-day regulatory activities, including handling multiple projects related to regulatory compliance enhancements.
* Management of regulatory submissions, including preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
* Support the team to obtain / retain country-specific regulatory registrations on a global basis.
* Monitor and ensure compliance with national and international regulatory requirements and quality standards.
Your Background:
We are looking for a talented professional with a Bachelor's degree in Engineering or Science, minimum 6 years of regulatory experience in the medical device industry, and excellent analytical and communication skills.
Bonus Information:
This role requires an enthusiastic self-starter who is willing to be a 'hands-on' contributor. If you are looking for a challenging opportunity to make a significant contribution to the company's success, we encourage you to apply.