At a Glance
- Tasks: Support product registration and compliance for innovative medical devices.
- Company: Join J&J MedTech, a leader in healthcare innovation.
- Benefits: Gain valuable experience in regulatory affairs with career growth opportunities.
- Other info: Dynamic team environment with a focus on health and safety.
- Why this job: Make a difference in healthcare by ensuring products meet global standards.
- Qualifications: Regulatory experience in medical devices and strong communication skills.
The predicted salary is between 30000 - 40000 £ per year.
- Position
- Regulatory Affairs Assistant
- Location
- Leeds, West Yorkshire, United Kingdom
- Job Summary
The Regulatory Affairs Assistant will help support New Product Development, Life Cycle Management, and product registration activities across the Depuy Synthes Portfolio.
Help support CE marking, UK CA mark and USA FDA submissions to project plans in accordance with Regulatory and Company requirements.
Duties & Responsibilities
- Provide full support to all registration activities, CE marking and US FDA submissions.
- Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions, and responses to regulatory bodies.
- Maintain processes for submissions, interim notifications, change notifications and periodic re-submissions.
- Maintain information on worldwide regulatory requirements and the status of product registrations.
- Liaise with all departments and project teams to coordinate timely applications for CE marking and other approvals.
- Provide support and advice to company colleagues, particularly product development, concerning global regulatory requirements.
- Provide support to maintenance of regulatory metrics and databases. Preparation of associated reports.
- Support compliance and audit activities during planning, preparation and response phases.
- Be aware of progress and developments of worldwide regulatory requirements.
- Responsible for communicating business-related issues or opportunities to next management level.
- Perform other duties assigned as needed.
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Experience
- Regulatory experience covering medical devices.
- Knowledge of worldwide regulatory procedures, especially for medical devices.
- Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements.
- Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
- Possess computer competency in Microsoft Office software, data collection and general analysis tools.
- Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations
- Excellent planning and organisational, communication skills.
- Product awareness and thorough knowledge of respective regulatory frameworks.
- Thorough and flexible.
- Cross culturally aware.
- Team player.
- Enthusiastic and committed.
- #J-18808-Ljbffr
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Assistant| J&J MedTech| in Leeds
✨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 Johnson & Johnson looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Assistant| J&J MedTech| in Leeds
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 Johnson & Johnson. 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 Johnson & Johnson
✨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 Johnson & Johnson’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
