Regulatory Affairs Specialist

Do you have experience in providing regulatory intelligence and ensuring a successful and timely product registrations in new countries and a will to work at a company with passion for purpose?

JOIN THE JOURNEY!

Do you have experience in providing regulatory intelligence and ensuring a successful and timely product registrations in new countries and a will to work at a company with passion for purpose?We are looking to recruit an experienced Regulatory Affairs Specialist to join a great team working with important products. 

About Brighter

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. Brighter´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/

You will be working with Actiste devices and services that are designed for daily diabetes management, with smart features aimed at helping to keep your blood glucose under control. 

JOB DESCRIPTION

As RA specialist, you will provide regulatory intelligence and support to regional managers/subsidiary heads of the company on the new markets (primarily in ASEAN and GCC regions), to ensure successful and timely product registrations in these countries. You will contribute to building the company’s global market entry road map, providing input based on up-to-date knowledge on country-specific regulatory requirements and product registration process time lines, with the purpose to maximize the efficiency of the company’s market entry in these regions.
You will also provide relevant insights (such as, information on the product registration process key players on each market) into shaping of the company’s initial footprint in the region, and support regional managers/subsidiary heads in building regional organizations, e.g. secure necessary local regulatory resources.

The position reports to the QA/RA manager at the company and you will be part of a global team based in Brighters headquarter in Kista.

Primary responsibilities include:

– Monitor the regulatory landscape (in the ASEAN and GCC regions initially, however countries and regions may vary according to business needs), communicate in a timely manner regulatory news, insights and intelligence within the company;
– Develop and communicate market entry time plans globally based on local regulatory processes in each market. Develop and communicate suggestions on market entry opportunities based on market intelligence and the company’s business needs;
– Identify the key players in the regulatory process on different markets, e.g. if the registration applications shall be made through either local entities, distributors, or a parent company organization. Use this knowledge to identify, plan and implement solutions to minimize time to market in the region in collaboration with regional managers/subsidiary heads;
– Provide input to identification and due diligence/evaluation of potential regulatory partners/local regulatory competence on each market, review contracts and agreements from the regulatory point of view, in collaboration with the company’s legal department;

YOUR COMPETENCIES & BACKGROUND

We are looking for you with a university degree in engineering, biological or medical science and a minimum of 5 years of documented experience in similar positions/regulatory affairs, preferably in a Medical Device company. Basic knowledge of International Regulatory Affairs, knowledge of regulatory processes in the Gulf region and/or South-East Asia is a merit. Technical knowledge of the medical devices and of the Company manufacturing processes preferred. Professional fluency in English is required.
To fit in with us and to succeed in this role, you have a genuine interest in medtech, as a person you are reliable, have a high sense of responsibility and strong interpersonal skills. You have a structured and organized way of working and can handle multiple tasks independently as well as manage priorities in order to meet projects timelines. It is important that you have a can-do attitude and the ability to creatively solve problems and to go the extra mile in order to succeed.

BE A BRIGHTERIAN

At Brighter we have a genuine interest in driving change, our mission is to improve the quality of life of millions of people’s. That goes for our teams as well. Our values are Smart, Friendly and Reliable and that is the guiding star for our attitudes and behaviors. 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 Brighter’s future success!

In this recruitment we collaborate with our partner Poolia. Do not hesitate to contact Krishan Johansson Hague if you are curious about the role, 072-070 16 53.

krishan.johansson-haque@poolia.se

We recommend that you submit your application as soon as possible as selection and interviews are held continually.

Looking forward to meet you!

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.

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