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- Tasks: Monitor global compliance standards and drive regulatory strategies for innovative healthcare products.
- Company: Join Arjo, a leader in healthcare solutions with a commitment to quality care.
- Benefits: Full-time role with opportunities for professional growth and impactful work.
- Other info: Collaborative environment with a focus on empowering movement in healthcare.
- Why this job: Make a difference in healthcare by ensuring product compliance and improving patient outcomes.
- Qualifications: Experience with medical device regulations and strong communication skills required.
The predicted salary is between 36000 - 60000 £ per year.
Senior Regulatory Standards And Tests Specialist
Arjo Houghton Regis, England, United Kingdom
Job type: Full-time, Permanent
Overview
Role focused on identification, monitoring, and interpretation of global product compliance standards and regulations; driving change control processes and regulatory impact assessments; contributing regulatory input to projects and strategies.
Main Responsibilities
- Identify, monitor, and interpret global product compliance standards/regulations; facilitate change control processes and drive communication and knowledge exchange regarding impact assessment; provide input to projects with regulatory strategies.
- Participate in product and corporate development projects, executing regulatory strategies to support business goals.
- Represent the Regulatory Affairs department in project meetings, providing regulatory guidance to ensure adherence to global requirements.
- Identify, monitor, and interpret new and revised standards/regulations; maintain procedures for monitoring standards/regulations and facilitate impact assessments.
- Drive communication forums for impact assessments and manage the TrackWise process for new/revised standards; coordinate gap analyses and provide certification strategy input for testing in test agencies.
- Assist in regulatory agency audits, update departmental procedures and participate in improvement projects.
- Act as member of the PRRC group with responsibility for ensuring Technical Files are established and approve EU Declarations of Conformity (DoCs); issue statements for investigational devices used in Clinical Investigations per EU MDR.
Required Knowledge/Skills/Experience
- Experience of working with international medical device regulations and registrations.
- Knowledge of coordination with test agencies and surveillance of certifications.
- Ability to synthesize technical information in standards and convert them into information understandable for R&D and licence application documents.
- Computer knowledge in Microsoft Word and Excel.
- Excellent written and verbal communication skills in English.
Personal Qualities
- Ability to synthesize complex information and coordinate cross-functional teams.
- Ability to render clear and accurate judgments and manage projects systematically.
Contact and application
If you have any questions please contact recruiting manager David Moynham, Senior Regulatory Compliance Manager, at david.moynham@arjo.com.
Last day to submit your application is September 30, 2025.
About Arjo
At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions promote safe and dignified patient handling, medical beds, personal hygiene, disinfection, diagnostics, and prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges. For more information about Arjo visit www.arjo.com.
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Senior Regulatory Standards And Tests Specialist employer: Arjo
Contact Detail:
Arjo Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Standards And Tests Specialist
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global product compliance standards. We recommend creating a cheat sheet of key regulations and recent changes to impress your interviewers with your expertise.
✨Tip Number 3
Showcase your project management skills! Be ready to discuss specific examples where you’ve successfully coordinated cross-functional teams or managed regulatory strategies. We love hearing about real-life experiences!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who align with our mission at Arjo.
We think you need these skills to ace Senior Regulatory Standards And Tests Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Standards and Tests Specialist role. Highlight your experience with international medical device regulations and any relevant projects you've worked on. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our mission at Arjo. Keep it concise but impactful, and don’t forget to mention specific experiences that relate to the job.
Showcase Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and free of errors. We love candidates who can synthesise complex information into understandable terms, so demonstrate this skill in your writing!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and submit your documents!
How to prepare for a job interview at Arjo
✨Know Your Regulations
Make sure you brush up on international medical device regulations and standards relevant to the role. Being able to discuss specific regulations and how they impact product compliance will show that you're not just familiar with the basics, but that you can also apply this knowledge practically.
✨Prepare for Scenario Questions
Expect questions that ask you to demonstrate your problem-solving skills in real-world situations. Think of examples where you've successfully navigated regulatory challenges or contributed to change control processes. This will help you illustrate your experience effectively.
✨Showcase Your Communication Skills
Since the role involves cross-functional collaboration, be ready to discuss how you've communicated complex regulatory information to non-experts. Prepare examples that highlight your ability to simplify technical jargon and ensure everyone is on the same page.
✨Engage with the Company’s Mission
Familiarise yourself with Arjo's commitment to empowering movement within healthcare. Be prepared to discuss how your values align with their mission and how you can contribute to their goals, especially in terms of regulatory compliance and patient safety.