Medical Device Regulatory Scientist

TN United Kingdom; Slough; On-site; GBP 45,000 - 70,000; Full time

Job summary

An established industry player is seeking a Medical Device Regulatory Scientist to join their Global Regulatory Affairs team. This exciting role involves handling regulatory activities for both marketed and developmental medical devices, ensuring compliance with global standards. You'll work closely with cross-functional teams to prepare submissions and maintain regulatory documentation, playing a vital role in the lifecycle management of innovative medical products. If you're ready to make a significant impact in the healthcare sector, this opportunity is perfect for you.

Qualifications

• Strong understanding of regulatory activities for medical devices.
• Proven ability to maintain compliance through Life Cycle Management.

Responsibilities

• Align with global regulatory strategy to ensure timely approvals.
• Prepare Technical Documentation Files for CE Marks and FDA clearance.
• Interact with Health Authorities for regulatory compliance.

Skills

Knowledge of drug and medical device manufacturing processes

Understanding of GMP/ISO standards

Familiarity with IVD, MDR, 510K, and IMDRF requirements

Experience working in cross-functional teams

Ability to synthesize technical data for documentation

Knowledge of drug delivery products

Job description

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Medical Device Regulatory Scientist, Slough

Client: UCB

Location: Slough, United Kingdom

Job Category: -

EU work permit required: Yes

Job Reference: 05844a7e1e83

Job Views: 7

Posted: 24.04.2025

Expiry Date: 08.06.2025

Job Description:

Make your mark for patients

We are looking for a Medical Device Regulatory Scientist to join our Global Regulatory Affairs team, based in Brussels (Belgium), Bulle (Switzerland), or Slough (UK).

The Medical Device Regulatory Scientist will handle regulatory activities for marketed and developmental medical devices and combination products within the Neurology, Immunology, and New Medicines units.

Responsibilities include:

• Align with global regulatory strategy to plan, prepare, review, and approve submissions for device components of combination products to ensure timely approvals.
• Prepare and maintain Technical Documentation Files to obtain CE Marks, Notified Body opinions, and FDA clearance.
• Interact with Health Authorities.
• Support global CMC regulatory strategies consistent with company practices and goals.
• Identify required device documents for submissions and coordinate their delivery to meet project timelines.
• Maintain regulatory compliance through Life Cycle Management activities such as changes, deviations, and improvements.

Qualifications and Skills:

• Knowledge of drug and medical device manufacturing processes.
• Understanding of GMP/ISO standards and change management systems.
• Familiarity with IVD, MDR, 510K, and IMDRF requirements.
• Experience working in cross-functional teams within a matrix organization.
• Ability to integrate medical device expertise into global regulatory strategies.
• Skills in synthesizing technical data for documentation and submissions.
• Knowledge of drug delivery products like syringes, inhalers, patches, and pumps.

If you want to learn more about R&D at UCB, please find more information here.

RANDATUCB

Are you ready to ‘go beyond’ to create value and make your mark for patients? If so, we would love to hear from you!