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 Quality Management/Regulatory Affairs department and is looking for a Post Market Surveillance Specialist who has experience from working with medical device and combination products, and be the contact person to consultants and authorities. The person 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 devices or pharmaceuticals. You are used to work globally.
You will belong to a team consisting of VP QM / RA, Regulatory Affairs Specialists, QA Specialist and Document controller.
In your role as Post Market Surveillance Specialist you are responsible for ensuring timelines of complaint handling, adverse events and medical device reporting activities. You are also responsible for Field Safety Corrective Actions and logging of customer complaints, ensuring proper and thorough investigation, trending and proper evaluation of patient risk. You will also ensure complaint responses and any reply to the complainant.
As Post Market Surveillance Specialist you will assure compliance regards to adverse events/medical device reporting with the applicable requirements (ISO 13485, EU Medical Device Regulation, FDA QSR and other national regulations).
You provide training during on-boarding of new staff and have the ownership of the Post Market Surveillance (PMS). You process by working with cross functional teams to obtain and summarise data origin from Complaints, Vigilance, Post Market Clinical Follow-up and CAPA.
You are responsible for establishing Periodic Safety Update Reports and write PMS plans and reports.
You have a natural science education in Life Science or equivalent and a minimum of 5 years work experience from a similar position and and experience from working internationally with medical devices. 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 firstname.lastname@example.org or +46 72 249 94 80.
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