Regulatory Affairs Associate

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

Job summary

Advanced Medical Solutions (AMS) is a leading medical device firm focused on tissue-healing technology. We seek a Regulatory Affairs professional to manage global regulatory documents, maintain approvals for the EU and USA, and drive strategy for change management.

You will support post-market surveillance, vigilance, and compliance with MDR, FDA 510(k) and ISO 13485. This role requires strong communication with authorities and cross-functional teams.

Qualifications

• Degree, or equivalent qualification, in a Life Science, or equivalent industry experience.
• Knowledge of GMP and Quality Systems standards, specifically FDA QSR and ISO 13485.
• Understanding of the European 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 stakeholders.

Responsibilities

• Create and maintain Regulatory Technical Documentation for Europe, USA and global regions including 93/42/EEC and 21 CFR Part 820.
• Maintain continued regulatory approval for European and USA markets and other territories.
• Contribute to regulatory strategy planning and change management.
• Perform post market surveillance activities including vigilance reporting and trend analysis.
• Review and approve documentation for Design History File and risk management artifacts.

Skills

Regulatory Affairs

FDA clearance

GMP knowledge

ISO 13485

Risk Management

Education

Degree in Life Sciences

Job description

Who are Advanced Medical Solutions? AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com

Job Description

• 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.