At a Glance
- Tasks: Join our global Regulatory Team and manage product registrations and compliance activities.
- Company: Flexicare, a leading medical device provider with over 35 years of experience.
- Benefits: Competitive salary, pension, performance bonuses, and health cash plan.
- Other info: Flexible working options and opportunities for professional development.
- Why this job: Make a real difference in patient care while growing your career in a dynamic environment.
- Qualifications: Degree in a scientific or engineering field and 1 year of regulatory experience.
The predicted salary is between 36000 - 60000 £ per year.
With over 35 years of experience, Flexicare is a leading designer and global provider of medical devices that enhance patient care. Headquartered in the UK, we support clinicians worldwide with class-leading devices and a global network of subsidiaries across over 100 countries. Flexicare has ambitious plans for international growth and we want you to be a part of our journey!
What You'll Do
- Based in our HQ in Mountain Ash, you will form part of our growing global Regulatory Team, taking ownership of product registration and associated activities within key registration jurisdictions.
- Contribute to the creation of labels for NPNI including UDI GS1 allocation.
- Support the control of Revisions to Declaration of Conformity.
- Contribute on the update and maintain of external regulatory portals (MHRA, FURLS, EUDAMED).
- Contribute on the update and maintenance of internal regulatory databases.
- Contribute to Non-priority EU MDR TFs completion project; contribute with DDE/risk management/GSPR/Label/IFU/TF summary.
- Lead on the resolution of regulatory compliance matters of devices cleared in the field (CFS, tender applications).
- Contribute to gap analysis of standards.
- Liaise with all departments to support Regulatory department activities.
Who You Are
- We believe you're the right fit if you have a Degree (or equivalent) in a scientific or engineering field.
- Minimum 1 year's experience as a Regulatory Affairs professional in Medical Devices.
- Particular knowledge of regulatory requirements for medical devices including Medical Device Regulation (MDR) 2017/745 & UK MDR 2002 Part II and ISO 13485 and ISO 14971.
- Strong collaborative skills - a confident and clear communicator with the ability to inform and influence diverse stakeholder groups.
- Proficient in various software packages including but not limited to Microsoft Word, Excel, Power Point and Adobe.
What You Will Get
- Competitive Salary in accordance with experience and capabilities.
- Pension.
- Annual Company performance bonus.
- Benefits package: Life Assurance (2 x salary), Income Protection (50% Salary), Health Cashplan, Monthly Benefit Fund - use towards other benefits or add to your pension pot.
- Balanced Working - 1 day working from home per week.
Regulatory Officer in Mountain Ash employer: Flexicare Global
Flexicare is an exceptional employer, offering a dynamic work environment in Mountain Ash where innovation meets collaboration. With a strong focus on employee growth and a comprehensive benefits package, including competitive salaries, performance bonuses, and flexible working arrangements, we empower our team to thrive while contributing to meaningful advancements in patient care globally.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Officer in Mountain Ash
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Flexicare Global looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Officer in Mountain Ash
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Flexicare Global. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Flexicare Global
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Flexicare Global’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
