About The Wayvio Project

Wayvio, a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, Wayvio is looking for a talented Ra QA Manager to take control of his/her future and help propel the company and set new industry standards.
This is the place for those who want to collaborate and those who want to innovate, for those who want to evolve and those who want to solve, for those who care and those who dare, for those who combine passion and ambition to take up great challenges. If you plan to play an active role in changing the dynamics of healthcare industry. You are in the right place.

-

You must be the one we are expecting!

We are looking for a dynamic and an experienced Quality & Regulatory Manager to join The Wayvio Project.
You will be part of an amazing team, taking on a position that will offer you a great opportunity to play a major part in the success of a growing business expanding its operations to

-

international markets. If you’re able to work within a team environment to create complex, innovative, high reliability systems promoting a more secure and responsible use of medical devices worldwide, this role is for you!

-

Your mission, should you choose to accept it...

  • Provide quality management and regulatory affairs leadership across the business within a highly regulated medical devices environment.
  • Define regulatory strategy to accompany and facilitate product adoption by customer.
  • Responsible for the daily management of the Quality Management System to the ISO 13485 standard and all regulatory submissions to the relevant authorities.

-

  • Raise our compliance level to reach the new MDR regulations & standards applicable to our business and product range, planning and delivering the Regulatory registration / submission documentation required to achieve global market access.
  • Ensure the planning and hosting of external Quality audits/ inspections while continuously improving our processes.

-

Here’s what it takes

  • A Bachelor’s degree in a relevant subject or suitable experience in a Regulatory/Quality role.
  • 3+ years of experience as a RAQA manager or similar role. Experience from the healthcare industry and IoT is a plus.
  • Excellent knowledge of MDD/MDR regulations as well as ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions.
  • Proven track record of regulatory submissions of technical files.
  • Proven track record of preparing for and managing successful Quality audits / inspections

-

Now for the soft skills...

  • Ability to think strategically and execute methodically.
  • Excellent written and oral communication skills.
  • You are results-oriented, upbeat and focused with a strong passion to learn and succeed.
  • Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
  • Ability to multitask and prioritize while managing multiple projects and day to day responsibilities.
  • Ability to influence cross-functional teams without formal authority.
  • Strong attention to detail and an ability to deal with ambiguity

-

Apply for this Job

Full time
Chicago area
Posted 5 months ago

About The Wayvio Project

Wayvio, a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, Wayvio is looking for a talented Ra QA Manager to take control of his/her future and help propel the company and set new industry standards.
This is the place for those who want to collaborate and those who want to innovate, for those who want to evolve and those who want to solve, for those who care and those who dare, for those who combine passion and ambition to take up great challenges. If you plan to play an active role in changing the dynamics of healthcare industry. You are in the right place.

You must be the one we are expecting!

We are looking for a dynamic and an experienced Quality & Regulatory Manager to join The Wayvio Project.
You will be part of an amazing team, taking on a position that will offer you a great opportunity to play a major part in the success of a growing business expanding its operations to

international markets. If you’re able to work within a team environment to create complex, innovative, high reliability systems promoting a more secure and responsible use of medical devices worldwide, this role is for you!

Your mission, should you choose to accept it…

  • Provide quality management and regulatory affairs leadership across the business within a highly regulated medical devices environment.
  • Define regulatory strategy to accompany and facilitate product adoption by customer.
  • Responsible for the daily management of the Quality Management System to the ISO 13485 standard and all regulatory submissions to the relevant authorities.

  • Raise our compliance level to reach the new MDR regulations & standards applicable to our business and product range, planning and delivering the Regulatory registration / submission documentation required to achieve global market access.
  • Ensure the planning and hosting of external Quality audits/ inspections while continuously improving our processes.

Here’s what it takes

  • A Bachelor’s degree in a relevant subject or suitable experience in a Regulatory/Quality role.
  • 3+ years of experience as a RAQA manager or similar role. Experience from the healthcare industry and IoT is a plus.
  • Excellent knowledge of MDD/MDR regulations as well as ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions.
  • Proven track record of regulatory submissions of technical files.
  • Proven track record of preparing for and managing successful Quality audits / inspections

Now for the soft skills…

  • Ability to think strategically and execute methodically.
  • Excellent written and oral communication skills.
  • You are results-oriented, upbeat and focused with a strong passion to learn and succeed.
  • Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
  • Ability to multitask and prioritize while managing multiple projects and day to day responsibilities.
  • Ability to influence cross-functional teams without formal authority.
  • Strong attention to detail and an ability to deal with ambiguity

Apply for this Job

Apply Online

A valid email address is required.
A valid phone number is required.

By submitting your application, you confirm you have read and accept our privacy policy