Senior Regulatory Affairs Specialist Job Description
Job Summary
We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our team on an initial 12-month contract. The successful candidate will be responsible for directing and preparing document packages for regulatory submissions, supporting change control activities, and leading the compilation of materials required in submissions, license renewal, and annual registrations.
Responsibilities
* Coordinate and prepare document packages for regulatory submissions.
* SUPPORT CHANGE CONTROL ACTIVITIES TO ENSURE GLOBAL APPROVAL AND IMPLEMENTATION OF PRODUCT AND PROCESS CHANGES.
* Compile all materials required in submissions, license renewal, and annual registrations.
* Collaborate with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support.
* Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
* Recommend changes for labeling and internal documentation, reports for regulatory compliance.
* Stay up-to-date with regulatory procedures and changes. Support review of internal procedures to ensure continuous compliance with all regulatory requirements.
* May have direct interaction with regulatory agencies on defined matters.
* Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
* Identify and develop best practices within the Regulatory Affairs Department, including continuous development initiatives.
Requirements
* Bachelor's degree or higher in Science or Engineering with a minimum of 5 years of relevant experience, preferably with Class III devices. A Regulatory Affairs qualification is desirable, but not mandatory.
* Regulatory experience in Medical Devices, Pharmaceuticals, Software in a medical device or similar regulated industry is required.
* Demonstrate strong teamwork and collaboration skills, with the ability to work effectively both individually and in teams.
* Strong technical knowledge and understanding of engineering, physiology, and medical device use principles.
* Ability to comprehend FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745, and international regulatory agency requirements.