Regulatory Affairs Specialist - MedTech (EU/US)

SmartRecruiters, Inc.; Clive; On-site; GBP 60,000 - 90,000; Full time

Job summary

Advanced Medical Solutions is seeking a Regulatory Affairs expert to lead regulatory submissions for EU/US markets and global territories. You will maintain approvals, contribute to strategy, and oversee post-market surveillance activities to ensure ongoing compliance across product lines.

You will collaborate with Regulatory, Clinical, Quality, and Engineering teams, ensuring documentation, risk management, and audits are handled efficiently in a regulated environment.

Qualifications

• Degree, or equivalent qualification, in a Life Science, or equivalent industry experience.
• Knowledge of GMP and Quality Systems, FDA QSR and ISO 13485.
• Understanding of MDR relevant to this role.
• Experience in preparation of and obtaining 510(k) clearance would be preferable.
• Experience in preparation and obtaining Design Dossier approvals would be preferable.
• Experience in maintaining technical files.
• Experience of working in a regulated environment.
• Understanding of Risk Management within a Medical Device industry.
• Ability to query and analyse data.
• Excellent communication skills both written and verbally with employees, customers, and Regulatory Authorities.

Responsibilities

• Create and maintain Regulatory Technical Documentation for European, USA markets, and other global territories including 93/42/EEC, (EU) 2017/745 and 21 CFR Part 820 requirements.
• Maintain continued product regulatory approval for the European, USA markets, and other global territories.
• Contribute to regulatory strategy planning and change management.
• Perform post market surveillance activities such as vigilance reporting, customer feedback, post market clinical trends and pro-active market feedback.
• Maintain the Pre-Market and Product Life Cycle processes and SOPs.
• Prepare regulatory documentation for submissions of changes to existing devices for European, USA markets, and other global territories.
• Support the creation of European, USA, and other global territories, strategy documentation for changes to existing devices.
• Review and approve documentation in support of Design History File compilation e.g. design inputs/outputs, clinical evaluation reports, risk management.

Skills

Regulatory affairs

GMP

Quality Systems

FDA QSR

ISO 13485

MDR knowledge

Risk Management

Data Analysis

Communication skills

Regulatory strategy

Education

Degree in Life Science

Job description

Advanced Medical Solutions is seeking a Regulatory Affairs expert to lead regulatory submissions for EU/US markets and global territories. You will maintain approvals, contribute to strategy, and oversee post-market surveillance activities to ensure ongoing compliance across product lines.

You will collaborate with Regulatory, Clinical, Quality, and Engineering teams, ensuring documentation, risk management, and audits are handled efficiently in a regulated environment.