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- Tasks: Monitor and analyse product performance post-launch to ensure safety and quality.
- Company: Join a leading company in medical technology focused on innovation and quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference by enhancing products that impact patient care.
- Qualifications: Strong analytical skills and experience in data analysis or regulatory compliance.
- Other info: Collaborative environment with opportunities to work across various teams.
The predicted salary is between 36000 - 60000 £ per year.
This position supports the development and execution of the Post Market Surveillance (PMS) Reporting Program’s activities to meet Elekta’s regulatory requirements and collate customer intelligence to enhance our products and solutions. This role is responsible for monitoring, analyzing and reporting on product performance once released to the market, identifying trends that may impact product safety or quality. The post-holder manages the timely production and submission of reports in accordance with schedules. You will also support internal and external audits of the PMS program.
Responsibilities:
- Develop and maintain work instructions and schedules of the PMS Reporting Program.
- Collect, review and analyze post-market data including customer feedback, complaints, service reports, and field performance data.
- Collaborate with SMEs for input, analysis and reviews of PMS reports and data.
- Maintain and execute the Post-Market Surveillance Plans in accordance with applicable regulations.
- Conduct trend analysis and signal detection to identify potential product issues or emerging risks.
- Prepare PMS reports, Periodic Safety Update Reports (PSURs), and other regulatory documentation.
- Support complaint investigations by collaborating with Engineering, Product Management, RA and Medical Affairs.
- Ensure timely escalation of safety-related issues and support risk management updates.
- Participate in cross-functional reviews to drive corrective and preventive actions (CAPA).
- Monitor regulatory changes and ensure PMS processes remain compliant and up to date.
- Contribute to internal audits, external audits and regulatory inspections.
- Maintain accurate records and documentation in compliance with quality system requirements.
Authorities:
- Communicate PMS Reporting to authorities on behalf of the business.
- Represent the PMS Reporting Program in internal and external audits.
- Represent the PMS Reporting Program in meetings and escalations.
Post Market Surveillance Specialist in Crawley employer: Elekta
Contact Detail:
Elekta Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Post Market Surveillance Specialist in Crawley
✨Tip Number 1
Network like a pro! Reach out to professionals in the field of Post Market Surveillance. Use platforms like LinkedIn to connect with people at Elekta or similar companies. A friendly message can go a long way in getting your foot in the door.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory requirements and PMS processes. We recommend creating a list of common interview questions related to product safety and quality, and practice your answers. Confidence is key!
✨Tip Number 3
Showcase your analytical skills! During interviews, be ready to discuss how you've handled data analysis or trend detection in past roles. Use specific examples to demonstrate your ability to identify potential product issues.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. Good luck!
We think you need these skills to ace Post Market Surveillance Specialist in Crawley
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Post Market Surveillance Specialist role. Highlight relevant experience and skills that match the job description, like your ability to analyse data and manage reports. We want to see how you can contribute to our PMS Reporting Program!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about post-market surveillance and how your background aligns with our needs. Be sure to mention any specific experiences that relate to monitoring product performance or collaborating with teams.
Showcase Your Analytical Skills: Since this role involves a lot of data analysis, make sure to showcase your analytical skills in your application. Whether it's through examples of past work or specific tools you've used, we want to know how you approach data and identify trends.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy and ensures your application goes straight to us. Plus, you’ll get to see more about our culture and what we’re all about!
How to prepare for a job interview at Elekta
✨Know Your PMS Basics
Before the interview, brush up on your knowledge of Post Market Surveillance and its importance in regulatory compliance. Familiarise yourself with key terms like PSURs and CAPA, as well as the specific regulations that govern PMS processes. This will show your interviewer that you’re not just interested in the role but also understand its critical context.
✨Showcase Your Analytical Skills
Since the role involves monitoring and analysing product performance, be prepared to discuss your analytical skills. Bring examples of how you've previously collected and interpreted data, identified trends, or contributed to reports. Highlight any experience you have with customer feedback analysis or service reports, as this will resonate well with the job requirements.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Think about potential product issues or emerging risks you might encounter in this role. Prepare to discuss how you would approach these situations, including how you would collaborate with cross-functional teams to drive corrective actions. This will demonstrate your proactive mindset and teamwork skills.
✨Stay Updated on Regulatory Changes
Regulatory compliance is a big part of this role, so make sure you’re aware of any recent changes in regulations related to Post Market Surveillance. Being able to discuss these changes and their implications during your interview will show that you’re committed to maintaining compliance and staying informed, which is crucial for the position.