At a Glance
- 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.
- Other info: We are an equal opportunity employer, welcoming diverse applicants.
- 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.
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-LjbffrPMS (Post-Market Surveillance)/Risk Specialist employer: Alivedx
At AliveDx, located near Edinburgh, we are dedicated to empowering diagnostic insights and transforming patient care through innovation. Our dynamic work culture fosters creativity and collaboration, offering employees a flexible working environment alongside comprehensive benefits such as private medical cover and life assurance. We prioritise professional growth, providing opportunities for training and development in a supportive atmosphere that values compliance and continuous improvement.
StudySmarter Expert Advice🤫
We think this is how you could land PMS (Post-Market Surveillance)/Risk Specialist
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Alivedx. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Alivedx!
We think you need these skills to ace PMS (Post-Market Surveillance)/Risk Specialist
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Alivedx that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Alivedx.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Alivedx does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Alivedx
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Alivedx. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Alivedx's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Alivedx. This shows your passion for the industry!
