Global Regulatory Affairs Associate

Advanced Medical Solutions; Winsford; On-site; GBP 55,000 - 70,000; Full time

Job summary

Advanced Medical Solutions in the United Kingdom seeks an experienced Regulatory Affairs professional to lead submissions and maintain regulatory compliance across EU, US, and additional markets.

You will manage GMP/ISO 13485 frameworks, MDR, 510(k) processes, and design dossier activities, coordinating with QA, clinical, and engineering teams.

The role requires strong communication with regulatory authorities and customers, ensuring timely approvals and ongoing post-market surveillance.

Qualifications

• Degree, or equivalent qualification, in a Life Science, or equivalent industry experience.
• Knowledge of GMP and Quality Systems standard, specifically 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.
• Ability to query and analyse data.
• Excellent communication skills both written and verbally with employees, customers, and Regulatory Authorities.

Responsibilities

• Maintain 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.
• Compilation of the application FMEA in support of Risk Management.
• Support the assessment and submission of quality management systems changes to regulatory authorities in European, USA, and other global territories, with input from other functions as required.
• Create, schedule and ensure adherence of Regulatory Technical Documentation updates.
• Provide regulatory input to major extensions to existing product lines and changes.
• Implement and maintain the post market surveillance process and SOPs.
• Review and analyse adverse event trending during PMS cycles.
• Support complaint reduction, and product performance improvement programmes.
• Support Risk Management System activities by supplying post market data to key internal stakeholders.
• Support product performance and manufacture process improvement programmes, to ensure compliance with Regulations and directives from European, USA markets, and other global territories including 93/42/EEC, (EU) 2017/745 and 21 CFR Part 820 requirements.
• Responsible for preparation and approval of Incident Reporting and FSCA/Recall reporting to meet regulatory requirements worldwide.
• Establish, manage and maintain good relationships with Regulatory Authorities and be the point of contact in respect of Vigilance (Incident Reporting, FSCA/Recall).
• Liaise with customer and Registration Holder for Incident Reporting and FSCA/Recall activities, within the terms of existing contractual obligations.
• Review and approval of key compliance records e.g. labelling, Instructions for Use (IFU).
• Generation of product labelling requirements.
• Establish, manage and maintain good relationships with Regulatory Authorities and be the point of contact in respect of regulatory submissions.
• Liaise with customers for Regulatory discussions, within the terms of existing contractual obligations.
• Act as Regulatory Subject Matter Expert for the preparation and participation in audits including FDA inspections, Notified Body and Global Authority and customer audits.
• Responsible for regulatory review of Regulations and Guidance, learn and understand changes, monitor and ensure conformance by implementing procedural updates.
• Interpret and apply medical device regulations to ensure conformance within the business, relevant to this role.
• Maintain catalogue of learnings from regulatory submissions and technical audits.
• Collaborates and interacts with internal teams, including Regulatory Affairs, Clinical, Quality, Engineering, Operations, Sales, Marketing, Customer Services.
• Promote and demonstrate the Company Values in the workplace.
• Promote health and safety policies in the workplace.

Skills

GMP knowledge

ISO 13485

MDR knowledge

510(k) experience

Design Dossier experience

Technical files maintenance

Regulatory submissions

Risk Management

Data analysis

Regulatory audits

Education

Life Science degree

Job description

Advanced Medical Solutions in the United Kingdom seeks an experienced Regulatory Affairs professional to lead submissions and maintain regulatory compliance across EU, US, and additional markets.

You will manage GMP/ISO 13485 frameworks, MDR, 510(k) processes, and design dossier activities, coordinating with QA, clinical, and engineering teams.

The role requires strong communication with regulatory authorities and customers, ensuring timely approvals and ongoing post-market surveillance.