Clinical Affairs Specialist

Getinge

Sweden - Stockholm/Uppsala

Apply now We currently have an opening for a Clinical Affairs specialist. You will be a part of a diverse team located in different countries with high level of expertise and knowledge.
Clinical Affairs Specialist
Getinge is a global company that designs and manufactures medical devices and life science equipment. In Critical Care (CC) business area, we mainly focus on products within intensive care, such as ventilators, anesthesia machines and advanced hemodynamic monitoring. We work in close collaboration with hospitals and research institutes.

We currently have an opening for a Clinical Affairs Specialist to join our corporate Medical Affairs team on a 1-year parental cover contract, with the potential possibility of extension. You will be a part of a diverse team located in different countries with a high level of expertise and knowledge. You will report to Clinical Affairs Manager, Critical Care within Acute Care

We are extremely proud of our values and culture in our company and are looking for someone with the same pride and passion we have for Getinge and our lifesaving products.

We impact the environment in various ways during a products life cycle, so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels

Job Responsibilities and Essential Duties
In this role you will work with the design and coordination of CC sponsored clinical studies for new and currently licensed products to support marketing approval of products and functions, including protocol development, regulatory requirements, investigator communication, timelines, budget and document management. You will also:

• Ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues
• Conduct the coordination and follow-up of CC agreements (Investigator Initiated Study agreements etc) with technical and clinical collaboration contacts
• Manage and execute post-market clinical research studies and surveys
• Ensure compliance with legal and regulatory requirements (e.g., GCP, ISO standards, MDR and CFR/FDA)
• Ensure clinical activities conducted are in a timely manner and within site budgets
• Develop reports for submission to regulatory agencies, as needed
• Monitor and ensure audit readiness of clinical study data and documents at sites to ensure regulatory and protocol compliance
• CRO management; supplier evaluation and proposal reviews
• Support in data analyses, clinical study reports and publication/presentation generation
• Support in medical writing of various regulatory documents such as clinical evaluation reports and literature reviews.

To be successful in this role, we think you have the following background:

• Life Sciences Degree, PhD preferable but not essential
• Experience in research and clinical studies; Good Clinical Practice and ISO 14155 familiarity
• Experience within the Medical Device industry and/or the life science industry
• Experience in FDA clinical investigation regulations (CFRs) is a plus.
• Experience in medical writing, including clinical evaluations and literature reviews in compliance to MEDDEV 2.7/1 Rev 4 and MDR 2017/745 is plus.
• Excellent knowledge of databases for scientific literature and bibliographic software, e.g. PubMed, EndNote
• Good knowledge of MS Office including Word, PowerPoint and Excel
• Highly proficient in spoken and written English

We highly value your personality and believe you have a strong sense of integrity, proactive and able to take initiative. You are a true teamplayer and excellent in building relations. You are used to work against deadlines and often exceeds expectations. You will have a broad responsibility and high ability to prioritize. We hope you have a curious mindset and willing to develop and improve routines and procedures.

About us
Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise ‘Passion for Life’ close to heart.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted MedTech company.

Application
For further information, reach out to Emma Perlhamre ([email protected]) or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.