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- Tasks: Ensure compliance with regulations and manage risk in product development.
- Company: AliveDx innovates diagnostic solutions to enhance 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, with experience in risk management and post-market surveillance.
- 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
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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 in Post-Market Surveillance and Risk Management. 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 medical device and diagnostics industry. Attend relevant conferences or webinars, and connect with people on platforms like LinkedIn. This can provide insights into the company culture at AliveDx and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your skills in risk management and compliance. Be ready to explain how you've successfully navigated challenges in previous roles, as this will highlight your problem-solving abilities.
✨Tip Number 4
Showcase your ability to work collaboratively by preparing examples of how you've supported team members in understanding risk management processes. This aligns with the role's requirement for providing guidance and training, making you a more attractive candidate.
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 at AliveDx. Tailor your application to highlight relevant experience in risk management and post-market surveillance.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in risk management and any specific projects related to post-market surveillance. Use concrete examples to demonstrate your skills and how they align with the job description.
Showcase Your Qualifications: Make sure to mention your science degree or equivalent qualifications prominently. If you have additional certifications or training related to medical device regulations, include those as well to strengthen your application.
Craft a Compelling Cover Letter: Write a tailored cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Mention how you can contribute to AliveDx's mission of empowering diagnostic insights and transforming patient care.
How to prepare for a job interview at Alivedx
✨Understand Regulatory Requirements
Familiarise yourself with the relevant regulations and standards applicable to medical devices and in vitro diagnostics. Being able to discuss these during your interview will demonstrate your knowledge and commitment to compliance.
✨Showcase Your Risk Management Experience
Prepare specific examples from your past experience where you successfully managed risk or conducted Post Market Surveillance activities. This will help illustrate your practical understanding of the role and its responsibilities.
✨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
Highlight your ability to work collaboratively within a team, especially in providing guidance and training on Risk Management and PMS. Share examples of how you've contributed to a positive team culture in previous roles.