Episurf Medical AB, founded as a spin-off from Diamorph AB in 2009, is a Swedish medical technology company aimed at helping people with painful joints to live a more active life by providing them with effective and individualized treatments. The patient-specific technology is developed in conjunction with top universities and clinical centres in Europe. Several short- and long-term pre-clinical studies were performed during 2009-2011 in order to verify the performance of the implants and to improve the functionality of the surgical technology. These studies were done in collaboration with Kungliga Tekniska Högskolan (The Royal Institution of Technology), orthopaedic surgeons at the Karolinska University Hospital, Charité University Hospital of Berlin and the Swedish University of Agricultural Sciences.
The Episurf idea focuses on the fact that every patient is unique. Given the extraordinary mechanical stress to which human joints are subject, surgical precision of the utmost degree is essential.  This can only be achieved consistently and safely by adapting a new approach in personalized healthcare. A field that Episurf is pioneering by developing and manufacturing individually customized implants and instruments to each patient’s unique anatomy and injury.
Episurf is based in Stockholm and has currently fifteen employees. The company is listed at NASDAQ OMX Stockholm.
Regulatory Affairs and QA Manager – Global TILLSATT
Opportunity
The market potential for a method to repair limited cartilage damage that provide better treatment results than existing alternatives such as micro-fracturing is estimated to have a potential of $980 million in the U.S. alone. Orthopaedic surgeons around the world feel that there is a treatment gap for the treatment of early osteoarthritis. 70% of surgeons feel that there is a lacking of procedure that ​​provide pain relief, provides an alternative to osteotomi / UKA / TKA and allows significant reduction of pain medication.
A successful concept benefits to the community through ​​an alternative to invasive surgery with subsequent long rehabilitation, less time to be able to return to work and, allow sport / exercise to prevent obesity.
The Episealer® products are patient unique implants that immediately recreate the original articular surface with a perfect adaptation to patient's anatomy. The company has two CE marked products; Episealer® femoral condyle – for the treatment of cartilage lesions in the knee condyle and Episealer® trochlea – for the treatment of cartilage damage in the area behind the knee cap.
This is an opportunity to work in a key role with a broad spectrum of responsibilities in an expanding Medtech company and to contribute to the growth of the company. The work is with international focus and performed not only within Regulatory Affairs & QA but also in close cooperation with other departments such as R&D, development and the international sales/marketing organisation. This role represents an outstanding opportunity to play an important role in Episurf’s market expansion. The role will contain a broad scope of responsibility and a huge opportunity to influence the Regulatory & Quality operation strategy and execution and manage that it is in line with the market expansion. The position demands that the new incumbent has influence, gravitas and presence in order to impact the business. You will be a part of a dynamic, skilled, collaborative and ambitious team with an open and pleasant atmosphere. There will be plenty of options for personal development within Episurf.

The position
The company has a lean organisation comprising fifteen employees, which includes clinical operations, technical development, Regulatory & QA, sales/marketing, finance and production.
The company now needs to appoint a Manager Regulatory Affairs & QA (RA&QA) with the main responsibility for:
1. ensuring that regulatory strategies and associated activities are effectively executed to meet the business objectives and legal requirements
2. the complete quality management system and ensure that it operates effectively within appropriate quality standards
3. develop plans concerning what kind of verifications the products are expected to undergo during development, how it should / can be manufactured, transported, etc. to meet each specific market requirements

You have a solid and documented experience of regulatory and QA issues including submission to authorities of medtech products in different markets (particularly in Europe and USA). The RA & QA Manager shall assure quality on products and processes by establishing and enforcing quality standards within the entire company. The RA&QA Manager reports to the CEO and is part of the management team. The role is placed at the Episurf headquarters in Stockholm.
The RA&QA will manage the activities of ensuring the implementation of appropriate and effective regulatory strategies in line with 93/42EEC in regards to product development. The appropriate person shall manage and oversee all maintenance activities for existing and coming CE-labelled products and align the Life cycle Management strategy accordingly. You expects to provide expert Regulatory and QA input to strategic decisions including portfolio review, prioritisation and external communication. Documented experience and a high knowledge in ISO-13485, 14971 and to QSR in USA is a must.
The work involves a lot of contacts both internally (to actively take part in the strategically discussion) and externally with international consultants and distributors, which places high demands on the understanding of different cultures as well as a great diplomatic skills. You have a strong drive with the ability to take initiative and are good at communicating. As the company is small, you must have a "can do" attitude and not be afraid to roll up your sleeves. While you're independent, you can also enjoy having a coordinating and project management role in a team working toward a common goal.

Qualifications
This pivotal role within Episurf requires a professional individual whose qualities and experience include the following parameters:
Requirement (must have):
BA or MSc in Technical/Natural Sciences.
At least 5 years’ international RA&QA experience within the medtech industry, preferably from a small / medium size company engaged in product development
Proven high knowledge of regulations for medtech products, standards for quality management systems (ISO 13485 and QSR) and risk management (ISO-14971)
Gained a solid understanding of RA&QA international requirements to facilitate and develop relevant tools and programmes based on the overall company regulatory strategy.
Desirably (nice to have):
Experience and an understanding of what it means to work in smaller companies with strong development potential
Knowledgeable concerning different IT systems relevant to the position (specific knowledge in the platform “share point” is an advantage)
Language:
Fluent in oral/written Swedish and English

For more information about the position and inquiries please contact Jarl Molin, recruitment consultants at Peak Search.
Telephone: +46 8 545 00 100, Mobile: +46 70 560 20 56
jarl.molin@peaksearch.se
http://www.peaksearch.se