Senior Post Market Surveillance and Clinical Specialist

Your Job

Phillips Medisize are seeking a Senior Post Market Surveillance and Clinical Specialist, to support development projects and post market activities for our medical devices.

Are you interested in working to ensure post market surveillance obligations are achieved? Are you interested in working to complete clinical evaluations for our devices?

If so, then you may be the person we are looking for.

Our Team

We are looking for someone to join our growing Post Market Surveillance and Clinical team. This team is a part of the Regulatory and Quality Organization based out of our Danish sites in Virum and Struer.

Phillips Medisize is an end-to-end provider of innovation, development and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries.

What You Will Do

• Plan the post market surveillance activities before the device is placed on the market.
• Ensure we as the device manufacturer are meeting our post market surveillance obligations.
• Complete clinical evaluations for devices which are robust and stand up to authority review.
• Collaborate with other domains and project managers.
  
  
  

Who You Are (Basic Qualifications)

• Bachelor's degree in relevant scientific or engineering discipline (e.g. life sciences, medical or pharmaceutical).
• Proven experience in a similar position or in a research position.
• Knowledge of regulatory requirements, such as (EU) 2017/745, ISO 14971, ISO 14155 and MEDDEV 2.7/1.
• Experience in medical/scientific writing (systematic review, clinical data appraisal)
• Knowledge in research methodology and searching in medical/medical device databases.
• Experience in completing literature searches (search strategy, appraisal, and quality evaluation)
• Strong organizational skills, and the ability to multi-task.
• Proactive and self-driven with a commitment to process improvement.
• Excellent written and verbal communication skills in English.
• Proficiency with MS Office.
  
  
  

What Will Put You Ahead

• Scientific doctorate (PhD) or medical doctorate.
• Experience working in the medical device industry.
• Experience in completing clinical evaluations of medical devices.
  
  
  

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.