MSI Pharma are representing a leading global notified body in their recruitment. Due to continued strategic growth within their Medical Devices business, they currently have a vacancy for an expert in their Active Implantable Medical Device team.
Within this role you will be responsible for:
· Carrying out detailed assessments of design and manufacturing data to ensure that Active Implantable Medical Devices meet the safety and performance requirements of the regulations
· Compiling Technical Documentation Assessment Reports (TDARs)
· Overall management and delivery of assigned design dossier assessments
· Working with Clinical Evaluation Specialists to determine the clinical impact of design changes and determining the level of clinical / technical assessment required
· Identifying the need for, engaging, and managing the delivery of assessments by other internal and external experts in the field of micro-biology, MRI, and biocompatibility etc.
· Coordinate and run client project management meetings to facilitate CE marking processes
· To conduct quotation reviews, contract reviews, process applications, and compile certification decisions under the CE and ISO 13485 certification schemes
· Planning and prioritising tasks logically according to regulatory priority, service level obligations and the needs of the business
· Maintaining accurate records of activities, and competency records that meet regulatory and BSI procedural requirements
· Delivering on site unannounced technical assessments
· Working with Team Training Lead and Head of Training to prepare and deliver technical training relevant to Active Implantable Medical Devices
· Keeping up to date with regulatory requirements and maintain a high level of awareness of changes in standards relating to the voluntary and mandatory certification in Europe and internationally
· Undertaking all activities in accordance with company Policies, Procedures and Protocols
· Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as, bio-medical, systems, mechanical, electronics or software engineering or other relevant sciences.
· Ten years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which five years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
· Proven knowledge and experience in the design, manufacturing and use of one or more of the following Active Implantable Medical Devices:
o Neuro stimulators
o Implantable cardioverter-defibrillator (ICD)
o Stimulation leads
o Infusion pumps
o Ventricular assist devices (VAD, LVAD)
o Artificial hearts
o Brachytherapy seeds and delivery systems
o Cochlear implants
o Implantable sensors including Medical Micro Electromechanical Systems (MEMS)
· Proven ability in the application of risk management techniques such as DFMEA, PFMEA, FTA etc.
· Proven track record managing difficult technical and / or commercial decisions and communicating effectively to key stakeholders
· Ability to understand, interpret, and explain legislation
· Ability to adapt in challenging situations whilst maintaining strict adherence to statutory requirements
· Sound administration, organisation, and project management skills, with appropriate follow-up actions, as well as attention to detail
· Excellent reputation for building relationships across various levels of an organization with a focus on cross-functional teams
· Excellent interpersonal and communication skills, both written and oral, internally, and externally and at junior and senior levels
· Proactive, self-motivated, and results-orientated with the ability to work independently
· Customer orientated with a focus on efficiency and delivery
· Conceptual thinker with ability to anticipate changing business and regulatory needs
· Familiarity with commonly used software tools (e.g. Windows, Excel, Word, Power Point) and ability to learn the companies systems and other as necessary e.g. MS Project
United States of America
US$110000 - US$130000 per annum
21 days ago