Regulatory Affairs Specialist

BONESUPPORT is an innovative commercial stage orthobiologics company, based in Lund, Sweden. The company 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 directly into the bone void. BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT®|BONE VOID FILLER (BVF), CERAMENT®|G* and CERAMENT® V* are all based on the company’s novel and proprietary technology platform.The company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology and foot and ankle. BONESUPPORT has about 80 employees with headquarter in Lund and offices in Frankfurt, Boston, Zurich, London and Haryana, India. There are also distribution networks in many EU countries. BONESUPPORT is listed on Nasdaq Stockholm. Further information is available at www.bonesupport.com.

BONESUPPORT now wants to strengthen their Regulatory Affairs department and is looking for a Regulatory Affairs Specialist who has experience from working with combination products, medical device / pharmaceutical and/or medical device / biologics and be the contact person to consultants and authorities. It is a new role and you will report to  the VP Quality Management / Regulatory Affairs who is a member of the management team. 

About the position

You should be able to contribute with skills and experience from working at companies with medical device pharmaceuticals and/ or biologics. You are used to work globally and will act as an advisor in different project groups and contribute with input to strategies.

You will belong to a team consisting of VP QM / RA, Regulatory Affairs Specialists, QA Specialist and Document controller.

In your role as Regulatory Affairs Specialist, you are responsible for ensuring that BONESUPPORT provides safe and appropriate products. You should be informed about the new regulations in several markets regarding medical devices, pharmaceuticals and biologics. 

This is an operational role and your geographic  area of ​​responsibility is global, but primarily geographic areas are e.g. MENA, Asia, Australia, and specific competence area is medical device in combination with biologics. You should coordinate, prepare and review regulatory documents for international applications and you are expected to maintain knowledge levels for existing and future legislation, standards and guidelines to interpret regulatory frameworks and ensure that they are communicated through business policies or procedures. Furthermore, you are responsible for that the company's products are labeled and adapted to the actual legislation and regulations governing  medical device/combination products

You will be responsible for compiling product information and have contacts with consultants and international authorities and also support the marketing department in questions regarding  product  development and change of products. You will participate and contribute with regulatory competence in development projects.

 

About you:

You have a natural science education in Life Science or equivalent and at least 10 years of work experience from a similar position and experience from working internationally with pharmaceuticals, medical technology and / or biologics. You have a very good knowledge in spoken and written in English and good knowledge of MS Office and electronic document management system.

In this role, personality is crucial for success. You are analytical, careful and aware of the details and quality. Furthermore, you are focused and structured and have the ability to quickly get involved in new tasks / questions. You are good at working together with others and can express yourself well both spoken and written. You also have the ability to review large amounts of information and make relevant priorities.You handle cases independently and you are a performance-driven person who is in a position to keep deadlines and deliver at a high pace.

In this recruitment process BONESUPPORT are working with Mandly Search & Selection. For further questions or more information please contact recruitment consultant Pernilla Agardh at pernilla@mandly.se or +46 72 249 94 80. 

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