Clinical Evaluation Manager - Global Medical Affairs at Wellspect AB
Wellspect Healthcare, with headquarters in Gothenburg, Sweden, is a leading global provider of innovative medical devices with a focus on helping people suffering from urinary retention or chronic constipation. Every day, more than 1 100 employees are dedicated to make a difference for those who need our products and services. Many of the people we serve have a spinal cord injury, enlarged prostate, spina bifida or multiple sclerosis. We are one of the world’s leading manufacturers of intermittent urinary catheters, with LoFric® as our most known brand. As a help to those with chronic or severe constipation we have developed what likely is the world’s most advanced irrigation system, the Navina Systems™, combining a high degree of user convenience, clinical effectiveness and connectivity into one really smart system. Wellspect HealthCare has a presence in more than 30 countries, and is a part of Dentsply Sirona, the worlds´ largest manufacturer of professional dental products and technologies with global headquarters in York, Pennsylvania, and international headquarters in Salzburg, Austria. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Please visit www.wellspect.com and www.dentsplysirona.com for more information. Are you an experienced CEM looking to take on a key role at one of the leading global providers of medical devices within bladder and bowel continence care? We have an agile team of experts waiting for you to join them in the important work of linking scientific evidence to regulatory requirements and commercial needs. If this sounds interesting, please keep reading. About the position As being the specialist in putting clinical and scientific evidence into a regulatory and business context the role requires high scientific knowledge, integrity and a broad understanding of external requirements/internal strategies. You will manage clinical evaluations on Wellspects full range of products covering urology and enterology. Your key accountabilities are: • To manage all parts of the of Clinical Evaluation process, including Clinical Evaluation Plan and Report • To define, and follow up on, Post Market Clinical Follow-Up initiatives • To optimize the use of scientific and clinical evidence to support successful registration, positioning and market access as well as secure compliant life cycle management • To represent the function in external (e.g. audits, inspections) and internal (e.g. projects, meetings, assessments) forums where your expertise is needed • To contribute from early product development and throughout the products life cycle • Process ownership of related processes. Who you are? We believe that you are a positive and driven person with the ability to extract, and communicate, relevant information from various sources such as scientific publications, reports and post market surveillance data. You are excellent in writing regulatory documentation. You are used to work independently digging deep into extensive data sources, yet with an appropriate sense of urgency. Strong stake holder management is key as your success partly is based on your cross functional interactions. You challenge and explore status quo with a clear ambition of constantly improving our way of working. We believe you have: • PhD degree, or similar • Approximately 5 years of documented relevant experience, preferably in conducting Clinical Evaluations • Deep understanding of applicable regulations and guidelines e.g. MDD, -MEDDEV 2.7.1. and MDR • Documented experience in literature search strategies, literature reviews and scientific writing • General understanding of medical device development and product life cycle requirements • Clinical experience, preferably within Urology a/o Enterology, is an advantage • Proficient in English (verbal and writing) Apply here In this recruitment we are cooperating with Your Talent AB. Do not hesitate contacting Recruitment Consultants Martina Träen (+46 722888220) or Johan Sjöberg (+46 761709851) if you have any questions. We are interviewing candidates continuously, so in order to enhance your chances, we recommend that you send us your application as soon as possible, however at latest November 29th 2019. Apply at www.yourtalent.se Welcome!