Regulatory Affairs Senior Associate - United Kingdom - Meet

Description

Job Title:
Senior Regulatory Affairs Associate
Fully remote

We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies.
Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.

As a Senior Regulatory Affairs Associate, you will play a crucial role in ensuring regulatory compliance for our medical devices.

You will collaborate closely with the Regulatory Affairs Manager and cross-functional teams to prepare and review regulatory submissions, manage design dossiers, and facilitate compliance with global regulations.

Prepare regulatory submissions for product approvals in various markets.
Participate in Design Control, Risk Management, and Post Market Surveillance activities.
Ensure compliance with the Vigilance System and regulatory requirements.
Update and review Instructions for Use (IFU), Packaging, and Labelling materials.
Perform other duties as required by the Regulatory Affairs department.

Bachelor's degree in a relevant field (e.g., Regulatory experience within the medical device or pharmaceutical industry is preferred.
Familiarity with Class 3 Medical devices is advantageous.
Strong understanding of global regulatory requirements and standards.
Proactive attitude with a commitment to quality and compliance.

Opportunity to make a meaningful impact on patient care through regulatory compliance.
Professional development and growth opportunities within a leading healthcare company.
Competitive compensation package and comprehensive benefits.

If you are passionate about regulatory affairs and want to contribute to the success of innovative medical technologies, we encourage you to apply for this exciting opportunity.