Quality Assurance/ Regulatory Affairs Manager - Brighter AB (publ)

If you have previous experience of a role as QA/RA Manager within MedTech and would like to be part of an exciting journey in a company with global presence – look no further!

Brighter is a health-tech company from Sweden with a vision of a world where managing chronic diseases is no longer a struggle. We believe a data-centric approach is key to provide smarter care for chronic conditions. Our daily-care solutions facilitate the flow of real-life treatment data between chronic-disease patients, their loved ones, and their care providers – improving quality of life, easing the burden on healthcare systems, and opening new opportunities for data-driven research. Blighter’s quality system is certified under ISO 13485. In 2019 the company won the Swecare Rising Stars Award. For more information visit https://brighter.se/

Join the journey!

In this role, you will be the business-minded spokesperson for Quality Assurance and Regulatory Affairs, and you will build and manage a strong and outstanding team that will lead these questions in an exemplary and business-oriented way. You will have a quite broad scope of responsibilities related to quality assurance, quality control, regulatory affairs, and compliance. You will establish and implement product registration strategies and plans for new markets and existing markets. You will also lead the work of getting product documentation in compliance with MDD. This role calls for an open mindset since you are being a part of a fast-growing company. You will perform a broad mixture of strategic and day-to- day responsibilities and be part of the leadership team for Operations. You will functionally report to Head of Operations and have a reporting line to CEO considering quality management for the company.

In your role you will

  • Lead, develop, and influence the future of the QA & RA strategy, function, and team members in a multicultural environment.
  • Be part of Blighter’s future, developing new innovative products and solutions, adding value for customers, healthcare, and patients.
  • Contributing to business strategies with the development and implementation of QA/RA OKRs.
  • Be responsible for resource management, planning, and training of the QA/RA team.
  • Overall responsible for the Quality Management System, QA/RA processes, including internal and external audits.
  • Registration strategies and driving the execution of registration plans for. development, regulatory approval, and optimal market access globally as required.
  • Ensuring Quality Assurance Agreements with suppliers are in place.
  • Ensuring that the company creates and maintains QMS documentation and relevant technical files (MDD/MDR, & IVDD).

To be successful in this role you have:

  • A Master of Science or related education, alternatively relevant job experience
  • A few years in any form of leadership position, building teams and providing guidance, with proven leadership skills that align with our client’s company culture and organizational structure
  • In-depth knowledge of the trends within the quality/regulatory and performance improvement space ISO 13485, ISO 14971, IEC 62304, MDD, IVDD & MDR
  • Experience of working with Quality Management Systems and processes within the MedTech industry
  • Experience of working in a global context with international relations

As a person, you are quality-conscious, communicative and you can collaborate with your closest colleagues as well as the entire business. In this role, sensitivity, order, and efficiency are also important. Furthermore, you are goal-oriented, can work independently and can handle work in an environment where conditions change.

Passon for purpose

Brighter is a health-tech company driven by a passion for our purpose to drive change in quality of life for patients, caregivers and people close to them. Our values are Smart, Friendly, and Reliable and this is the guiding stars for our how we act towards each other internally and to our external partners. How we lead ourselves and work together sets our company culture, and we thrive on having a company culture where we team up and win together. For us it’s important that you are a team player and want to contribute to improving the world and Blighter’s future success! Would you like to be a part of a company with talented and driven colleagues? 

In this recruitment we collaborate with our partner Talentor. Don´t hesitate to contact Karin Lundmark if you are curious about the role, +46 72 727 0225.

 

Apply today as we are looking to fill this position as soon as possible. We look forward to your application!

 

 

Additional information

  • Remote status

    Flexible remote

Or, know someone who would be a perfect fit? Let them know!

Kista

Borgarfjordsgatan 18
164 40 Kista Directions PeopleandCulture@brighter.se +46(0)8-550 088 20 View page

Three reasons to join us.

  • Passion with purpose.

    Today millions of people live with chronic conditions. At Brighter you get the chance to be part of making their lives easier and improve health care globally. You get to go to work and make a change, every day, together with a passionate team. You might say that working at Brighter is more a lifestyle than a job, yet said with the insight that our work life balance is a key to success.

  • Focus on company culture.

    Diversity is a natural part of our culture and we dare to say that we are all talents. We speak broken English with team members from all over the world. We are passionate and proud about our products and services, which forms us to be ambitious teams organized in a non-hierarchical network organization with our slogan - “Team up - winning together”.

  • Tech and digital nerd? No worries, you are among friends!

    At Brighter we are really into tech and digital development, all our functions are driving digital transformation in the way they can. We aim to practice as we preach as Brighter is a data driven company where technology is our base. Our company roots are Swedish, as is our headquarter based in Kista, Stockholm. Upon that we have engaged teams in Dubai and Jakarta and more to come as we aim to improve health care globally!

We are human innovation.

We exist to improve people's quality of life.

Our daily-care solutions facilitate the flow of real-life treatment data between chronic-disease patients, their loved ones and their care providers – improving quality of life, easing the burden on healthcare systems, and opening new opportunities for data-driven research.

Teamtailor

Applicant tracking system by Teamtailor