Assistant Regulatory Manager

JR United Kingdom; Portsmouth; On-site; GBP 35,000 - 50,000; Full time

Job summary

A global leader in Footcare is seeking an Assistant Regulatory Manager based in Portsmouth. The successful candidate will play a critical role in ensuring regulatory compliance and supporting product registrations across various markets. This position requires a scientific background, around 2 years of relevant experience, and strong knowledge of regulatory frameworks within Medical Devices and Cosmetics sectors.

Qualifications

• At least 2 years relevant regulatory experience.
• Experience with ISO 13485 and dossier preparation.
• Understanding of global regulatory environments.

Responsibilities

• Support registration and regulatory requirements across multiple markets.
• Prepare and review regulatory documents for product registration.
• Maintain and update regulatory databases.

Skills

Regulatory compliance

Technical dossier creation

Quality management systems knowledge

Knowledge of regulatory classifications

Project management

Education

Honours degree in a scientific field

Job description

Assistant Regulatory Manager, Portsmouth, Hampshire

Client:

Our client is a global leader in Footcare, with a portfolio spanning medical devices, cosmetics, orthotics, and personal care. They are seeking to add an Assistant Regulatory Manager to their team.

Location:

Portsmouth, Hampshire, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

1

Posted:

04.06.2025

Expiry Date:

19.07.2025

Job Description:

The Assistant Regulatory Manager will support the delivery of NPD/EPDs to global markets, oversee the rollout of existing products, and ensure regulatory compliance. The role involves supporting regulatory planning across innovation, providing SME knowledge on core dossier requirements, and ensuring regulatory activities are completed efficiently and consistently.

The Role:

1. Support registration and regulatory requirements across multiple markets to facilitate a global pipeline.
2. Define processes within the Global Regulatory Footcare team to optimize speed to market and efficiencies.
3. Prepare and review regulatory documents for product registration in assigned markets.
4. Keep up-to-date with regional and national regulations, guidelines, and advisory documents.
5. Participate in product development and marketing projects for local and international launches.
6. Maintain and update regulatory databases with accurate product records.
7. Provide regulatory training and support to teams.
8. Develop regulatory strategies for successful product registration and variations globally.
9. Build knowledge and intelligence within the regulatory function to ensure a 'right first time' approach.
10. Collaborate with partner functions to align data requirements and timelines.
11. Develop strong relationships with local regulatory contacts for efficient market access.
12. Foster proactive relationships with partner functions.

The Requirements:

1. Honours degree in a scientific field or equivalent experience.
2. At least 2 years of relevant regulatory experience in dossier/technical file creation and global registrations.
3. Experience with quality management systems, e.g., ISO 13485.
4. Knowledge of regulatory classifications such as Medical Devices, Cosmetics, REACH, Biocides, or willingness to develop this knowledge.
5. Understanding of regional and global regulatory environments and their impact on dossiers and registrations.
6. Experience with preparing and submitting dossiers, variations, and renewals.
7. Knowledge of global product development practices, rules, and guidelines.
8. Awareness of factors influencing the regulatory environment, including emerging guidelines.
9. Ability to deliver work independently within time, cost, and quality standards in high-pressure settings.

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Created on 04/06/2025 by JR United Kingdom