Regulatory Affairs Associate

Recruitment Solutions Folkestone Ltd; Folkestone; Hybrid; CAD 21,000 - 36,000; Part time

Benefits offered by this job

Holiday accrual

Benefits

Job summary

Recruitment Solutions Folkestone Ltd in Folkestone, UK, seeks a Regulatory Affairs Associate on a temporary contract to support regulatory compliance and product registrations across Europe, the Middle East and Africa. You will coordinate with internal teams and distributors to keep products compliant and market-ready.

This role requires strong organisational skills, attention to detail and experience with EU MDR 2017/745.

Qualifications

• Experience with EU MDR 2017/745 and regulatory requirements.
• Strong organisational and project management skills.
• Excellent attention to detail and accuracy.
• Strong written and verbal communication skills.
• Ability to build effective relationships with internal and external stakeholders.
• Proactive and self-motivated approach with ability to work independently.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office, including Word, Excel, Teams and SharePoint.

Responsibilities

• Support regulatory enquiries and product registration activities for commercial teams, distributors and internal stakeholders.
• Prepare, coordinate and submit documentation for new product registrations and maintenance of licences.
• Research, interpret and apply regulatory requirements across EMEA markets.
• Collaborate with Quality, R&D, Marketing, Supply Chain and Legal to compile regulatory dossiers.
• Manage registration projects and ensure submissions progress on timelines.
• Monitor product changes and coordinate regulatory notifications or submissions to authorities and distributors.
• Coordinate signing, legalisation and authentication of regulatory documentation.
• Maintain records of registrations, licences and submissions in regulatory databases.
• Organise electronic regulatory files per internal procedures.
• Liaise with distributors, authorities and trade associations to support market access.
• Produce reports on registration status, compliance activities and milestones.
• Support continuous improvement of regulatory processes and ways of working.
• Provide general administrative support to the Regulatory Affairs team.

Skills

EU MDR knowledge

Project management

Attention to detail

Comm skills

Stakeholder management

Proactive attitude

Analytical skills

MS Office

SharePoint

Tools

Excel

SharePoint

Job description

Location: Folkestone, Kent – Hybrid Working

Contract: Temporary long term

Sector: Medical Devices / Consumer Healthcare / Regulatory Affairs

The Opportunity

My client is seeking a Regulatory Affairs Associate to join their Global Markets team on a temporary contract basis, supporting regulatory compliance and product registrations across Europe, the Middle East and Africa (EMEA).

This is an excellent opportunity to join an established international organisation and gain broad exposure across Medical Devices, Medicines and Food Supplements.

The successful candidate will play an important role in supporting new product registrations, maintaining existing licences and coordinating regulatory activities across multiple international markets. You will work closely with internal stakeholders, regulatory authorities and distributor partners to help ensure products remain compliant and can be successfully brought to market.

The position would suit a highly organised and detail-focused regulatory professional who is comfortable managing multiple projects and working across different regulatory frameworks.

Key Responsibilities

• Support commercial teams, distributors and internal stakeholders with regulatory enquiries and product registration activities.
• Prepare, coordinate and submit documentation for new product registrations and the maintenance of existing licences.
• Research, interpret and apply regulatory requirements across EMEA markets.
• Work cross-functionally with teams including Quality, R&D, Marketing, Supply Chain and Legal to compile and maintain technical documentation and regulatory dossiers.
• Manage registration projects and ensure submissions and approvals progress in line with agreed timelines.
• Monitor product changes and coordinate any necessary regulatory notifications or submissions to distributors and regulatory authorities.
• Prepare and coordinate the signing, legalisation and authentication of regulatory documentation.
• Maintain accurate records of registrations, licences and submissions within internal regulatory databases and systems.
• Organise and maintain electronic regulatory files in accordance with internal procedures.
• Liaise with distributors, regulatory authorities, trade associations and other external stakeholders to support market access.
• Produce reports and provide updates on registration status, compliance activities and project milestones.
• Support continuous improvement initiatives across regulatory processes and ways of working.
• Provide general administrative support to the wider Regulatory Affairs team as required.

About You

Essential

• Good understanding of EU Medical Device Regulation (EU MDR 2017/745) and associated regulatory requirements.
• Strong organisational and project management skills, with the ability to manage multiple priorities simultaneously.
• Excellent attention to detail and a commitment to accuracy.
• Strong written and verbal communication skills.
• Ability to build effective relationships with internal and external stakeholders.
• Proactive and self-motivated approach, with the confidence to work independently and use initiative.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office, including Word, Excel, Teams and SharePoint.

Desirable

• Previous experience within Regulatory Affairs, Product Registrations, Compliance or a related discipline.
• Experience supporting registrations for Medical Devices, Medicines, Food Supplements or Consumer Healthcare products.
• Knowledge or experience of regulatory requirements across Europe, the Middle East and Africa.

What's on Offer

This temporary position provides an excellent opportunity to work within a global Regulatory Affairs environment, with exposure to a broad portfolio of products and international markets.

You will benefit from a hybrid working arrangement, a collaborative team environment and the opportunity to further develop your international regulatory experience.

If you have experience within Regulatory Affairs and are looking for your next opportunity within a varied, internationally focused role, we would be keen to hear from you.

Up to £14.00 per hour + Plus Holiday Accrual and Benefits