At a Glance
- Tasks: Monitor and analyse product performance to ensure safety and quality post-launch.
- Company: Join a leading healthcare technology company dedicated to improving patient care.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic role with opportunities for collaboration and career advancement.
- Why this job: Make a real difference in healthcare by enhancing products that help patients.
- Qualifications: Analytical skills and a passion for healthcare technology are essential.
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 AB
Contact Detail:
Elekta AB 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 healthcare and regulatory fields on LinkedIn. Join relevant groups and engage in discussions to get your name out there and show your interest in Post Market Surveillance.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of PMS processes and regulations. We recommend creating a list of common interview questions related to product safety and quality, and practice your answers to feel more confident.
✨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 internal career site! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of our team at Elekta.
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, especially in areas like data analysis and regulatory compliance.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about supporting healthcare professionals and how your background makes you a great fit for our team at StudySmarter.
Showcase Your Analytical Skills: Since this role involves monitoring and analysing product performance, be sure to include examples of your analytical skills. Mention any specific tools or methodologies you've used in past roles that relate to post-market surveillance.
Apply Through Our Website: Don't forget to apply through our internal career site! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Elekta AB
✨Know Your Stuff
Make sure you understand the Post Market Surveillance process inside out. Brush up on relevant regulations and be ready to discuss how you would handle data analysis and reporting. This shows you're not just interested in the role, but that you’re prepared to hit the ground running.
✨Showcase Your Analytical Skills
Prepare examples of how you've previously monitored and analysed product performance or customer feedback. Be specific about the tools and methods you used, and how your insights led to improvements. This will demonstrate your capability to identify trends and potential risks.
✨Collaboration is Key
Since this role involves working with various teams, think of instances where you've successfully collaborated with others. Be ready to share how you’ve worked with subject matter experts or cross-functional teams to drive corrective actions or improve processes.
✨Stay Updated on Regulations
Familiarise yourself with the latest regulatory changes that could impact post-market surveillance. Being able to discuss current trends and how they affect PMS processes will show that you’re proactive and committed to compliance, which is crucial for this role.