Principal Regulatory Affairs Specialist - Medical Devices -Hampshire- Hybrid working

Mosaic Regulatory Solutions; England; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

A global regulatory firm in Hampshire is seeking a Regulatory Affairs Principal Specialist for Medical Devices. The ideal candidate will possess a Bachelor’s degree and have 6-8 years of experience navigating medical device regulations. Responsibilities include product labelling, technical writing, and evaluating manufacturing changes. This role supports hybrid working arrangements, with 3 days in the office.

Qualifications

• 6-8 years of experience in medical device regulatory affairs.
• Knowledge of MDD and MDR regulations.
• Ability to work independently or in a team setting.

Responsibilities

• Expertise in product labelling.
• Technical writing for regulatory submissions.
• Evaluating manufacturing changes for global regulatory submissions.

Skills

Expertise in product labelling

Technical writing for regulatory submissions

Strong communication skills

Education

Bachelor’s degree in a scientific or technical discipline

Tools

Electronic document management systems

ISO 13485 understanding

Job description

Overview

Role: Regulatory Affairs Principal Specialist- Medical devices

Location: Hampshire

Hybrid working - 3 days in the office

Salary: On application

A global company in Hampshire is seeking a talented individual to join their expanding team in the role of Principal Regulatory Specialist for Medical Devices. With a Bachelor’s degree in a scientific or technical field and 6-8 years of experience in medical device regulations, the ideal candidate will have expertise in product labelling, technical writing, and evaluating manufacturing changes for global regulatory submissions.

Responsibilities

• Expertise in product labelling.
• Technical writing for regulatory submissions.
• Evaluating manufacturing changes for global regulatory submissions.

Qualifications

• Bachelor’s degree in a scientific or technical discipline
• 6-8 years of experience in medical device regulatory affairs
• Proficiency in reviewing and approving product labelling
• Knowledge of MDD and MDR regulations
• Experience with electronic document management systems
• Understanding of ISO 13485 requirements
• Ability to work independently or in a team setting
• Strong communication skills and ability to engage with stakeholders at all levels

If you are interested in this permanent role and would like to learn more about the responsibilities and expectations, feel free to reach out for a detailed job description and a confidential discussion regarding this opportunity. #MedicalDevices #RegulatoryAffairs #CareerOpportunity