The Role:
PE Global is recruiting for a Senior Regulatory Affairs Specialist on behalf of a leading medical device company. This is an initial 12-month contract role.
Responsibilities:
* Coordinate and prepare document packages for regulatory submissions.
* Support change control activities to ensure global approval and implementation of product and process changes.
* Lead or compile materials required for submissions, license renewal, and annual registrations.
* Collaborate with business unit Regulatory Affairs 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 labelling and internal documentation, reports for regulatory compliance.
* Maintain awareness of regulatory procedures and changes. Ensure review of internal procedures to guarantee continuous compliance with all regulatory requirements.
* Interact with regulatory agencies on defined matters as needed.
* Support regulatory compliance activities, including manufacturing site registration & GMP audits.
* Identify and develop best practices within the Regulatory Affairs Department, including continuous development initiatives.
Education & Experience:
* Bachelor's degree/master's in Science or Engineering (Level 8 Honor's Degree). Minimum 5 years of relevant experience, preferably with Class III devices. A Regulatory Affairs qualification is desirable.
* Regulatory experience in Medical Devices, Pharmaceuticals, Software in a medical device or similar regulated industry.
* Dynamic team player able to work effectively and proactively on individual and team activities.
* Strong technical knowledge with critical thinking and decision-making skills. Ability to comprehend engineering, physiology, and medical device use principles.
* Collaborate with global cross-functional teams and create alignment with team members.
* Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), and international regulatory agency requirements.
* Provide guidance, coaching, and training to other employees within the job area.