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- Tasks: Ensure compliance with regulations and manage risk in product development.
- Company: AliveDx innovates diagnostic solutions for better patient care with over 30 years of expertise.
- Benefits: Enjoy flexible working, pension plans, private medical cover, and life assurance.
- Why this job: Join a dynamic team focused on innovation and customer-centric solutions in healthcare.
- Qualifications: Science degree or equivalent, experience in risk management and PMS activities required.
- Other info: We are an equal opportunity employer, welcoming diverse applicants.
The predicted salary is between 36000 - 60000 £ per year.
PMS (Post-Market Surveillance)/Risk Specialist Company: AliveDx At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we prioritize patient health by creating innovative solutions designed for faster diagnostic results. Location: Near Edinburgh (EH26 0BF) Role Overview: The PMS/Risk Specialist will ensure compliance with all relevant regulations through the completion of Product Risk and Post Market Surveillance (PMS) activities. This role involves managing risk throughout the Design Control Process for new projects and through Core QMS processes for products on the market. YOUR MISSION Your main responsibilities will include: Ensure Product Risk Management Processes are compliant with relevant Risk Management Regulations. Conduct all duties in compliance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP). Provide support, guidance, and training to team members in Risk Management and PMS. Maintain knowledge of new or updated regulatory requirements and industry standards. Participate in regulatory inspections or certification audits. Promote risk culture within the organization, including Risk Based Approach and Continuous Improvement. Act as a Risk Management Team Representative during Third Party Audits. Create and update PMS documentation in line with IVDR requirements. Carry out PMS activities for compliance with required schedules. Lead and support all Product Risk Management activities. YOUR COMPETENCIES Science Degree or Equivalent qualification. Experience in risk management. Experience in Post Market Surveillance activities (PMS). Ability to prepare coherent regulatory reports. Specialist knowledge of regulations applicable to medical devices and in vitro diagnostic medical devices. Great attention to detail, communication, and collaboration skills. WHAT WE OFFER A dynamic and growing environment. An opportunity to cultivate innovation and customer centricity. A flexible working environment and a range of benefits including pension, private medical cover, life assurance, and more. Interested? We look forward to receiving your application. AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals. Seniority Level Associate Employment Type Full-time Job Function Manufacturing and Science Industries Biotechnology Research and Medical Equipment Manufacturing #J-18808-Ljbffr
PMS (Post-Market Surveillance)/Risk Specialist employer: Alivedx
Contact Detail:
Alivedx Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land PMS (Post-Market Surveillance)/Risk Specialist
✨Tip Number 1
Familiarise yourself with the latest regulations and standards related to Post-Market Surveillance and risk management in the medical device sector. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the industry, especially those who work in risk management or PMS roles. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully managed risk or conducted PMS activities. Highlighting your practical knowledge will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to collaborate and communicate effectively with cross-functional teams. Being able to illustrate how you've worked with others to promote a risk culture or improve processes will be a key asset in this role.
We think you need these skills to ace PMS (Post-Market Surveillance)/Risk Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the PMS/Risk Specialist position. Familiarise yourself with terms like Post Market Surveillance and Risk Management to demonstrate your knowledge in your application.
Tailor Your CV: Customise your CV to highlight relevant experience in risk management and Post Market Surveillance activities. Use specific examples from your past roles that align with the job description to showcase your qualifications.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for patient care and innovation in diagnostics. Mention how your skills can contribute to AliveDx's mission and values.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at Alivedx
✨Understand the Regulatory Landscape
Familiarise yourself with the key regulations and standards related to Post-Market Surveillance and Risk Management in the medical device sector. Being able to discuss these during your interview will demonstrate your expertise and commitment to compliance.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in risk management and PMS activities. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
✨Emphasise Attention to Detail
Given the nature of the role, attention to detail is crucial. Be ready to discuss how you ensure accuracy in your work, especially when preparing regulatory reports or documentation.
✨Demonstrate Team Collaboration Skills
The role involves providing support and training to team members. Share examples of how you've successfully collaborated with others in previous positions, highlighting your communication skills and ability to foster a positive team environment.
