Looking for a

Ra QALead

-

Chicago area

About SMADE

SMADE a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, SMADE is looking for a talented Ra Qa Lead 🥇 to take control of his/her future and help propel the company and set new industry standards.

SMADE 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.

 

Creativity, playfulness, optimism, excellence, openness, that’s words which define us!

Be ready to change the medical experience together? Let’s start!🚩

-

You must be the one we are expecting!

We are looking for a dynamic and an experienced Quality & Regulatory Lead to join SMADE.
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!

-

Come as you are! In SMADE team, we are … IKEA assembly geniuses, triathletes, Mamma Mia lovers, Apple addicts, golf players and much more.

 

So if you too, you are a cooker 👨‍🍳 , a globetrotter 🌏, a dancer 💃🏽 , a hard-rock fan 🎶 or a hockey player 🏒and lot of other things and you think you have all chance to fulfill this position, don’t hesitate and hit “Apply”.

-

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.

-

👩🏽‍💻For our teammates, the ideal colleague is …

  • 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

-

You are...

  • You are devoted, enthusiastic, autonomous, curious and fun! 🥳
  • 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

-

Our promise...

🔝An opportunity to take part in an innovative project at the service of the medical devices, and the improvement of life.

😁A strong team spirit, a caring work atmosphere and a ton of humor, come with your best jokes.

👨‍👦Work/life balance.

💡Express yourself, at SMADE we encourage all new ideas.

-

Our recruitment journey...

It’s a cruise 🚢 one along which you will undoubtedly meet Marion 👩🏻‍💼our HR pilot who is there to steer you in the right direction. She will introduce you to your future skipper 👩🏽‍✈️who will give you an overview of the route the company has taken as well as the future destinations it intends on reaching. And finally, a last meeting with our Captain 👨🏻‍✈️

 

So if you are an adventurer 🪂 like us and you are looking to explore new horizons, then jump aboard!

-

Apply for this Job

Full time
Chicago area
Posted 8 months ago

Looking for a

Ra QA
Lead

Chicago area

About SMADE

SMADE a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, SMADE is looking for a talented Ra Qa Lead 🥇 to take control of his/her future and help propel the company and set new industry standards.

SMADE 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.

 

Creativity, playfulness, optimism, excellence, openness, that’s words which define us!

Be ready to change the medical experience together? Let’s start!🚩

You must be the one we are expecting!

We are looking for a dynamic and an experienced Quality & Regulatory Lead to join SMADE.
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!

Come as you are! In SMADE team, we are … IKEA assembly geniuses, triathletes, Mamma Mia lovers, Apple addicts, golf players and much more.

 

So if you too, you are a cooker 👨‍🍳 , a globetrotter 🌏, a dancer 💃🏽 , a hard-rock fan 🎶 or a hockey player 🏒and lot of other things and you think you have all chance to fulfill this position, don’t hesitate and hit “Apply”.

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.

👩🏽‍💻For our teammates, the ideal colleague is …

  • 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

You are…

  • You are devoted, enthusiastic, autonomous, curious and fun! 🥳
  • 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

Our promise…

🔝An opportunity to take part in an innovative project at the service of the medical devices, and the improvement of life.

😁A strong team spirit, a caring work atmosphere and a ton of humor, come with your best jokes.

👨‍👦Work/life balance.

💡Express yourself, at SMADE we encourage all new ideas.

Our recruitment journey…

It’s a cruise 🚢 one along which you will undoubtedly meet Marion 👩🏻‍💼our HR pilot who is there to steer you in the right direction. She will introduce you to your future skipper 👩🏽‍✈️who will give you an overview of the route the company has taken as well as the future destinations it intends on reaching. And finally, a last meeting with our Captain 👨🏻‍✈️

 

So if you are an adventurer 🪂 like us and you are looking to explore new horizons, then jump aboard!

Apply for this Job

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