CLINICAL RA MANAGER
BRIEF COMPANY PROFILE
OUR CLIENT is a leading provider of technologically advanced medical devie systems used in intraoperative and diagnostic procedures. For more than 40 years the market leading branded solutions of our client have been used to improve the practice of medicine in procedure driven markets such as urology, surgery and point of care. These real-time visualization solutions support surgeons in achieving the best patient outcomes by allowing visualization of organs at the time of surgery, as well as imaging the path of surgical devices during the procedure, and imaging at the end of surgery.
Thus, our client’s technological landmarks enable surgeons to make immediate and well-informed decisions by guiding them through critical steps – from staging through intervention to validation – all in one procedure, with one image taking less than a second.
The Clinical RA Manager will assume responsibility for the execution of clinical evaluations by providing quality administrative and project management support. In addition, the Clinical RA Manager will provide clinical input during product development and support verification and validation activities. The position will further be responsible for organizing Post Market Clinical Follow up (PMCF) plans and PMCF reports.
The role will coordinate with all members of the Clinical Affairs team and internal and external stakeholders to successfully execute all activities leading to compliant Clinical Evaluation Reports (CERs). Thus, the position relies on building successful relationships with R&D/Engineering, Product Management, Clinical Affairs, Clinical Marketing and other internal stakeholders, as well as regulatory authorities per country and CROs.
Consequently, the position calls for a proficient RA professional with sound Clinical RA experience from an international medical device setting. The ideal candidate has in-depth understanding of regulatory procedures, including clinical data analysis and maintenance as well as clinical evaluation and risk assessment. Moreover, the ideal candidate display strong commitment to quality and compliance, is organized and detail oriented with a high level of initiative, self-motivation and energy, while he/she is reliable, responsive and customer focused.
Clinical RA Manager
Global Director, RA
Responsibilities & Tasks:
Creating and maintaining Clinical Evaluation Reports (CERs) to meet requirements of MEDDEV 2.7/1 rev. 4 and review articles, as required.
Organize PMSCF reports.
Providing sound scientific and technical advice during product testing phase.
Developing, analysing and maintaining clinical data.
Assisting engineering team by providing input during risk management assessment processes including product safety and usability from clinical perspective.
Supporting the clinical evaluation and post market surveillance processes to meet the new MDR requirements.
Writing and updating Periodic Summary Update Reports (PSUR), and Summary of Safety and Clinical Performance (SSCP) reports for the EUDAMED database.
Compiling submission packages for Ethics Committee(s) and Local Regulatory Authorities.
Key success criteria:
Delivering effective and appropriate clinical evaluations – hereunder CER’s, PMCF’s a.o.
Taking clear role-specific ownership on key projects while contributing with knowledge-sharing and support.
Ensuring seamless cooperation with key stakeholders while achieving practical and pragmatic solutions.
University level degree, preferably M.Sc., within Science, Engineering, Medical or Technical field.
Fluently oral and written English, and preferably also good knowledge of oral and written Danish.
Ideal experience and competencies:
Extensive experience in a similar position in a global medical device setting.
Preferably experience with clinical trials.
Experienced in cooperation with relevant authorities.
Working knowledge of ISO 14155 Clinical investigation for medical devices for human subjects – Good Clinical Practice.
Adapt to changes in applicable regulatory requirements.
Communicates the central issues in a discussion in a clear, fluent and precise manner. Produces written material, which is clear, fluent, precise and easy to understand for the recipients.
Is able to establish and maintain relations with people at all levels internally as well as externally. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills. Develops and maintains networks.
Is concerned with reaching and maintaining quality and sets high standards for performance and execution – for oneself and for others.
Is proactive and able to take own initiatives without hesitation. Actively seeks influence and commence activities on own initiative.
Works systematically and is highly organized and methodical, while displaying perseverance and consistency towards commenced responsibilities, tasks and projects.
Collaborates and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information.
Builds strong and effective organization and champions the philosophy of continuous improvement with a high degree of integrity fostering transparency, reliability and trustworthiness – personally and professionally