Global Regulatory Affairs Specialist to BONESUPPORT

"Restoring health to improve the quality of life for patients with bone disorders." The Mission is clear and BONESUPPORT AB wants you to be a part of the journey. Here is an opportunity to join an amazing team in an agile and creative company with extraordinary products. Come and join BONESUPPORT as Global Regulatory Affairs Specialist!

OM TJÄNSTEN

BONESUPPORT is an innovative and rapidly growing orthobiologics company, based in Lund, Sweden. In 2017, BONESUPPORT AB was listed on the stock exchange. The company has 50 coworkers based in Lund and 55 spread globally. To further strengthen the company, BONESUPPORT is now looking for an engaged and driven Regulatory Affairs Specialist to be a part of our Global Quality Management & Regulatory Affairs team, located in our HQ in Lund, Sweden.

At BONESUPPORT you will be working together with skilled, dedicated and very nice people who enjoy working in a fast growing and innovative organization. We offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance. We believe in our journey and take pride in what we do!

You are offered
- No boredom! BONESUPPORT is a stimulating workplace where you are challenged daily
- The opportunity to work for a company whose products are based on interesting technology and a scientifically trustworthy foundation and years of studies
- An international arena with a global reach and colleagues in Germany, Great Britain, the United States, and several other countries

ARBETSUPPGIFTER

Work tasks


* Compile medical device files, prepare and submit regulatory submissions as IDE, 510(k), PMA, Canadian Medical Device licenses and CE dossiers for EU. Support approval in other regions as required
* Support regulatory compliance for BONESUPPORT’s products for Europe, North America, and other relevant markets
* Ensure maintenance of registration including renewals and establishment/device listing
* Liaise with international authorities/notified bodies, regulatory consultants and other external experts
* Provide regulatory advice and support to project teams, the organization in general, as well as distributors
* Perform regulatory intelligence of new or updated requirements
* Support other activities/projects as relevant
* In your role, you will collaborate closely with other parts of the company, e.g. R&D, Operations, Marketing and Sales. Other key relationships are external partners, such as suppliers, authorities, and other external organizations


VI SÖKER DIG SOM
- Education: Relevant University degree in e.g. Engineering/Life Science or equivalent
- Experience: You are In the beginning of your career within the medical device industry, with some experience from regulatory affairs or other relevant areas such as QA or QC
- A good understanding of what it means to be working in a regulated environment (acquainted with requirements such as European Medical Device Regulation MDD/MDR, MDSAP, US FDA legislation, ISO13485 and other relevant ISO standards)
- Language: Very good knowledge of spoken and written English
- Good knowledge of MS Office and preferably also electronic document management systems

It is meritorious if you have
- Experience from working internationally
- Experience working with implantable and/or combination products

To succeed in the role, your personal skills are:
- Results-oriented
- Quality-oriented
- Cooperative
- Problem solver

At BONESUPPORT we value personal skills as much as professional qualifications, and in this role, personality is crucial for success. You are good at working together with others and can express yourself well both spoken and written. You handle tasks independently and you are a performance-driven person who can keep deadlines and deliver at a high pace. You are analytical and have attention to detail. Furthermore, you are focused and structured and have the ability to quickly get involved in new tasks/questions, also when it requires processing of large amounts of information.

Our recruitment process

This recruitment process is handled by Academic Work and it is our client’s wish that all questions regarding the position is directed to Academic Work.

Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the next phase. The process includes two tests: one personality test and one cognitive test. The tests are tools to find the right talent for the right position, to enable equality, diversity, and a fair process.

INFORMATION OM FÖRETAGET
BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden, and the net sales amounted to SEK 329 million in 2022. Please visit www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.