Regulatory Affairs Specialist

BONESUPPORT, a Swedish medical device company, is now looking for a Regulatory Affairs Specialist who will be working in a global environment with preparation of regulatory submissions, maintenance and support of existing device approvals. In this role you will keep the company up to date with regulatory requirements, provide regulatory advice and together with project team set requirements on products in order to comply with regulations. Your responsibilities also include maintenance of regulatory procedures, including labelling procedure and review of labelling materials. You will be working closely with not only the organization, but also with regulatory authorities, distributors and external consultants with regulatory expertise.

We are offering a dynamic, innovative and challenging position where you will be able to work with Regulatory Affairs in a global role.

Business: BONESUPPORT

City: Lund

Job type: Temporary position, until 2015.07.31

Deadline for applications: 2014.05.04

More information: This recruitment will be managed by Proffice Life Science. For more information about this position please contact Recruitment Consultant Camilla Wern 0733-436098. The selection process is on-going so please apply as soon as possible, however not later than 2014.05.04. Please send in your application (CV, cover letter as well as your references) in English via www.profficelifescince.se.

Qualification:

We are looking for a person with the following experience and qualification:

. University degree in science or technology

. A minimum of 3 years experience from Regulatory Affairs, preferably in the medical device industry.

. Good knowledge of global medical device regulations for orthopedic implants, of standards for quality management system (ISO 13485 and QSR) and for risk management (ISO 14971)

. You have excellent English in speech and writing.

. It is a great advantage to have knowledge/experience of:

- Combination products where the medical device has the primary mode of action

- Design dossier submissions and 510(k) applications



On a personal level, you have excellent communications skills. You are self-motivated and you have the ability to plan and execute activities with minimal supervision. You strive to deliver results. You like to work in a structured way with an eye for details. We place great emphasis on personal qualities for this role.

Organization/Business description:

BONESUPPORT is an emerging leader of injectable bone graft substitutes for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications. CERAMENTT is an injectable, synthetic bone substitute that mimics the properties of cancellous bone, allows for controlled resorption to support future bone ingrowth and is injectable under local anesthesia for minimally invasive surgery. CERAMENT's unique biologic properties deliver a consistent, pre-packed and ready-to-use formulation to facilitate optimal delivery. CERAMENTT|G is the first CE-marked injectable gentamicin antibiotic eluting ceramic bone graft substitute. CERAMENTT|G is indicated to promote and protect bone healing in the management of osteomyelitis, (bone infections) in CE marked countries. CERAMENTT|G is not available in the United States.

CERAMENTT is a fully developed product platform that is commercially available in the U.S. and Europe and is revolutionizing the treatment of fragility and other fractures caused by disease and trauma. Scientific research of CERAMENT spans more than eleven years. Over forty-five pre-clinical, clinical and animal studies have been conducted and more than 9,000 patients have been treated with CERAMENT. The company was founded in 1999 and is based in Lund, Sweden with subsidiary locations in the US and Germany. To learn more about BONESUPPORT please visit www.bonesupport.com