Senior Regulatory Affairs Lead – Medical Devices (EMEAP)

Abbott; Witney; On-site; GBP 60,000 - 90,000; Full time

Job summary

Abbott in Witney is seeking a Senior Specialist Regulatory Affairs to lead regulatory activities for new products and changes across the EMEAP region, coordinating with global teams to ensure timely approvals in Europe, Middle East, Africa and Pakistan.

You will build regulatory submissions, work with Notified Bodies and regulatory authorities, and mentor junior colleagues while advancing Abbott's pipeline and product portfolio in a fast-paced healthcare environment.

Qualifications

• Bachelor’s degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
• Knowledge of MDR 2017/745 Regulations and ISO13485 is essential, additionally, knowledge of IVDR 2017/746 is preferred
• Experience within a medical device or healthcare manufacturing industry in a regulatory or quality role.
• Experience of Technical File creation and maintenance, as well as post market changes
• Experience of working with Notified Bodies and/ or other regulatory bodies
• Excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.

Responsibilities

• Formulate, develop and lead business critical regulatory strategies for the EMEAP region.
• Act as the regulatory subject matter expert in design control projects, assessing changes and managing roll out programs for existing products and new launches.
• Become a technical expert in ADC devices and support interactions with EU Notified Body/UK Approved Body, as well as competent authorities, as required
• Manage the creation and development of EU & UK Technical files in accordance with MDR 2017/745, IVDR 2017/746 and other application regulations.
• Provide coaching and mentoring to more junior team members
• Identify and implement process improvements and efficiencies per the global regulatory affairs strategy.

Skills

Regulatory affairs

Regulatory strategy

Regulatory submissions

Communication

Education

Bachelor’s degree or equivalent in a Scientific discipline

Job description

Abbott in Witney is seeking a Senior Specialist Regulatory Affairs to lead regulatory activities for new products and changes across the EMEAP region, coordinating with global teams to ensure timely approvals in Europe, Middle East, Africa and Pakistan.

You will build regulatory submissions, work with Notified Bodies and regulatory authorities, and mentor junior colleagues while advancing Abbott's pipeline and product portfolio in a fast-paced healthcare environment.