Regulatory Affairs Senior Specialist - Supply Chain
This a Full Remote job, the offer is available from: Europe
It's fun to work in a company where people truly believe in what they are doing!
The Regulatory Affairs Senior Specialist plays a key role in ensuring regulatory, quality, and safety compliance across a diverse regional portfolio. In this senior position, you will act as a trusted subject matter expert, partnering with internal teams and external stakeholders to maintain audit readiness, support market access, and uphold the highest standards of regulatory governance across multiple EMEA countries.
Key Responsibilities
• Take site-level responsibility for regulatory compliance and ongoing audit readiness, ensuring documentation, processes, and systems meet relevant EMEA and local regulatory requirements.
• Manage medical device vigilance and reporting activities within the region in line with applicable EMEA and country-specific regulations, timelines, and procedures.
• Prepare, review, and maintain regulatory declarations and documentation required for shipping, import, export, and trade into EMEA markets.
• Ensure local quality assurance activities support compliance with internal quality systems, regulatory standards, and continuous improvement objectives.
• Oversee country-level product and site compliance, including fulfilment of Extended Producer Responsibility (EPR) and other environmental or stewardship obligations where applicable.
• Coordinate the creation, review, and maintenance of regional Safety Data Sheets (SDS) and hazard labelling to ensure alignment with relevant chemical, safety, and transport regulations, and maintain accurate records of local registrations, approvals, certifications, and licences.
Job Requirements
• Proven experience in regulatory affairs within the medical device, pharmaceutical, or related life sciences sector, with demonstrable exposure to EMEA markets.
• Strong working knowledge of relevant EMEA and local regulations (e.g. EU Medical Device Regulation, vigilance and reporting requirements, SDS and hazard labelling standards, and environmental/EPR frameworks).
• Excellent written and verbal communication skills, with the ability to convey complex regulatory requirements clearly to a range of stakeholders.
• Strong organisational skills, with the proven ability to manage multiple projects, deadlines, and country‑specific requirements simultaneously.
• High level of accuracy and attention to detail in preparing, reviewing, and maintaining regulatory documentation and records.
• Ability to work both independently and collaboratively in a multidisciplinary, multicultural environment, with proficiency in standard office IT tools and document management systems.
• Eligibility to work in the UK and willingness to complete right to work checks in accordance with applicable legislation.
Desirable skills (not essential):
Experience working with regulatory authorities or notified bodies in EMEA; familiarity with EPR schemes and environmental compliance; experience supporting inspections or audits; additional European language skills; and relevant professional certifications in regulatory affairs or quality management.
What We Offer
• The opportunity to make a meaningful impact on patient safety and product compliance across a broad and varied EMEA portfolio.
• A supportive, inclusive working environment that values diversity and provides equal opportunities, in line with the Equality Act 2010 and applicable employment legislation.
• Ongoing training and professional development to support your growth and progression in regulatory affairs.
• Potential for flexible, hybrid, or remote working arrangements, subject to business needs and local regulations.
• A standard benefits package, including access to wellbeing and development resources, in accordance with local policies and applicable law.
If you are a regulatory affairs professional looking to take on a senior regional remit and contribute to high-impact work across EMEA, we would love to hear from you. Join our team and help ensure safe, compliant, and sustainable access to products for patients and customers across the region. Please submit your application, including your CV, outlining how your experience aligns with this role.
Come Be Part Of A Mission that Matters!
From inside the farm gate to our dinner plates, Neogen protects the world’s food supply. Through a variety of animal healthcare products, to food safety solutions for dangerous bacteria, allergens, toxins, drug residues and much more, Neogen is there — and you can be too.
This offer from "Neogen Corporation" has been enriched by Jobgether.com and got a 78% flex score.
Apply tot his job
Apply To this Job
It's fun to work in a company where people truly believe in what they are doing!
The Regulatory Affairs Senior Specialist plays a key role in ensuring regulatory, quality, and safety compliance across a diverse regional portfolio. In this senior position, you will act as a trusted subject matter expert, partnering with internal teams and external stakeholders to maintain audit readiness, support market access, and uphold the highest standards of regulatory governance across multiple EMEA countries.
Key Responsibilities
• Take site-level responsibility for regulatory compliance and ongoing audit readiness, ensuring documentation, processes, and systems meet relevant EMEA and local regulatory requirements.
• Manage medical device vigilance and reporting activities within the region in line with applicable EMEA and country-specific regulations, timelines, and procedures.
• Prepare, review, and maintain regulatory declarations and documentation required for shipping, import, export, and trade into EMEA markets.
• Ensure local quality assurance activities support compliance with internal quality systems, regulatory standards, and continuous improvement objectives.
• Oversee country-level product and site compliance, including fulfilment of Extended Producer Responsibility (EPR) and other environmental or stewardship obligations where applicable.
• Coordinate the creation, review, and maintenance of regional Safety Data Sheets (SDS) and hazard labelling to ensure alignment with relevant chemical, safety, and transport regulations, and maintain accurate records of local registrations, approvals, certifications, and licences.
Job Requirements
• Proven experience in regulatory affairs within the medical device, pharmaceutical, or related life sciences sector, with demonstrable exposure to EMEA markets.
• Strong working knowledge of relevant EMEA and local regulations (e.g. EU Medical Device Regulation, vigilance and reporting requirements, SDS and hazard labelling standards, and environmental/EPR frameworks).
• Excellent written and verbal communication skills, with the ability to convey complex regulatory requirements clearly to a range of stakeholders.
• Strong organisational skills, with the proven ability to manage multiple projects, deadlines, and country‑specific requirements simultaneously.
• High level of accuracy and attention to detail in preparing, reviewing, and maintaining regulatory documentation and records.
• Ability to work both independently and collaboratively in a multidisciplinary, multicultural environment, with proficiency in standard office IT tools and document management systems.
• Eligibility to work in the UK and willingness to complete right to work checks in accordance with applicable legislation.
Desirable skills (not essential):
Experience working with regulatory authorities or notified bodies in EMEA; familiarity with EPR schemes and environmental compliance; experience supporting inspections or audits; additional European language skills; and relevant professional certifications in regulatory affairs or quality management.
What We Offer
• The opportunity to make a meaningful impact on patient safety and product compliance across a broad and varied EMEA portfolio.
• A supportive, inclusive working environment that values diversity and provides equal opportunities, in line with the Equality Act 2010 and applicable employment legislation.
• Ongoing training and professional development to support your growth and progression in regulatory affairs.
• Potential for flexible, hybrid, or remote working arrangements, subject to business needs and local regulations.
• A standard benefits package, including access to wellbeing and development resources, in accordance with local policies and applicable law.
If you are a regulatory affairs professional looking to take on a senior regional remit and contribute to high-impact work across EMEA, we would love to hear from you. Join our team and help ensure safe, compliant, and sustainable access to products for patients and customers across the region. Please submit your application, including your CV, outlining how your experience aligns with this role.
Come Be Part Of A Mission that Matters!
From inside the farm gate to our dinner plates, Neogen protects the world’s food supply. Through a variety of animal healthcare products, to food safety solutions for dangerous bacteria, allergens, toxins, drug residues and much more, Neogen is there — and you can be too.
This offer from "Neogen Corporation" has been enriched by Jobgether.com and got a 78% flex score.
Apply tot his job
Apply To this Job