Regulatory Affairs Associate

Job Details 

• Create and maintain Regulatory Technical Documentation in compliance with 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.

What will this role involve?

• 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.
• 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.

What we're looking for?

• Degree, or equivalent qualification, in a Life Science, or equivalent industry experience.
• Knowledge of relevant GMP and Quality Systems standard, specifically with FDA Quality System Regulation and ISO 13485 relevant to this role.
• Understanding of the European Medical Devices Regulation (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.
• Demonstrated organisational skills.
• Ability to work under pressure to meet process/project time frames, regulatory requirements and company requirements.
• Competent IT skill in preparing files.
• The ability to influence and challenge others in a constructive way to deliver improvements.
• Excellent communication skills both written and verbally with employees, customers, and Regulatory Authorities.