DIRECTOR, RA - IT SOLUTIONS
BRIEF COMPANY PROFILE
Our client is a global leading provider of technologically advanced acute care solutions that simplify and automate all phases of acute care testing. The company’s advanced solutions and products help healthcare professionals get fast and accurate information on the most critical parameters in acute care testing. This is the foundation for making immediate and well-informed decisions on the treatment of critically ill patients in clinical settings such as emergency care, intensive care, anesthesiology, cardiac surgery, neonatal care and wound care.
The company is located in Greater Copenhagen.
The Director, RA - ITS will head up an RA team of 5 FTE’s – consisting of 3 employees located in Bangalore, and 2 employees working in Denmark (and also covering the company’s Transcutaneous monitoring products). The role will be responsible for the company’s ITS RA strategy and will be working with relevant stakeholders at our client as well as with an external network of people. The team will have a strong focus on supporting R&D IT projects to ensure market approvals for our client's different product areas such as Immunoassays, Transcutaneous Monitors, Samplers, IT Solutions and the Blood Gas products. Moreover, the team will undertake RA maintenance of existing products and drive improvement projects.
Overall areas of responsibility:
IT solutions R&D support.
Regulation and standards/guidances.
Internal process compliance.
Internal & External Working groups.
Consequently, the position calls for an experienced RA executive with strong potential or a proven track record of organizational leadership, experience and interest in leading specialists and building effective teams in the medical device/IVD industry. Moreover, the ideal candidate has demonstrable successor capabilities.
Director, RA - IT Solutions
Senior Director, RA
Limited - 20 days per year
Responsibilities & Tasks:
Leading and managing a mixed team of experienced specialists.
Developing employees through continuous development planning and driving successful and measurable employee engagement.
Supporting R&D and value engineering projects (mainly in relation to design control activities).
Providing support to currently marketed products, managing the regulatory activities and supporting the product care activities of the assigned product portfolio e.g., review changes, labeling, promotional material, product changes and documentation for compliance.
Maintaining product technical files for ongoing activities related to compliance with Global Regulatory directives and regulations.
Reviewing, interpretating and reporting of Regulatory leadership on product specific regulatory issues that may have impact on the business units, the corporation, or the customer. May work with Quality department to influence mindset of quality.
Ensuring that the team takes a consulting and active supporting role in relation to the R&D project teams during the development of new products and during the product life cycle.
Assessing and communicating regulatory risks and challenges, interfaces with the lifecycle team.
Accomplishing conformity evaluation for new and existing products.
Planning of Deliverables with other Regulatory Affairs professionals (USA, Canada, China, etc.) for product registrations, including compilation of corresponding Software- and Hardware-Reports
Working in a cross-functional, multi-site team to ensure alignment and harmonization
Key success criteria:
Ensuring strong performance of the RA team.
Securing timely delivery on R&D projects and countryspecific registrations according to business needs and successful preparation and leading of negotiations with RA authorities.
Delivering high workplace assessments and Engagement Index (EI).
Successfully driving continuous improvement, including excellent utilization of Continuoys Improvement tools, to build future RA muscle.
Successfully driving broad cross-functional stakeholder collaborations, alignment and communication.
Degree preferably at M.Sc.-level within Science, Engineering, Pharmacy, Biology, Biochemistry or the like.
English – fluent (verbally and written).
Ideal experience and competencies:
3-5 years of Manager experience in Regulatory Submissions and Project Support, preferably in the area of regulated instrument and software development.
Experienced in the regulatory framework for IVD Medical Devices and/or Medical Devices with good know-how of IVDD/VDR and international regulations for IVD devices and the related international registrations.
Preferably experienced in the area of technical product compliance (product safety, RoHS Directive, Electromagnetic Compatibility Directive, Low Voltage Directive and Machinery Directive) and the related conformity assessment procedures.
Preferably gained knowledge of design control requirements for In-Vitro Diagnostic (Software, instruments, analytical systems and solutions).
Strong RA knowledge and experience with medical device legislation (MD and/or IVD) worldwide and especially within classification of software for medical devices, standalone or combined.
Experience with risk assessments and evaluations required by the regulations described above.
Experience with supporting product development teams for the implementation of regulatory requirements in the technical product development and supported the registrations.
Familiar with systematically monitoring changes to regulatory requirements and standard updates.
Experienced in setting the direction for the department/strategy
Makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through.
Is proactive and able to inspire others and is able to take own initiatives without hesitation. Actively seeks influence and starts up actions on own initiative.
Dedicated work-spirit with a distinct ability to work in an environment with changing priorities daily
Is undeterred and persistent despite resistance and difficulties, carries on when faced with adversity.
Defines a clear vision and moves strategy to action. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies.
Capable of building strong organizations based on collaboration. Collaborates and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information.
Works systematically and is highly organized and methodical, while displaying perseverance and consistency towards commenced responsibilities, tasks and projects.
Champions the philosophy of continuous improvement with a high degree of integrity fostering transparency, reliability and trustworthiness – personally and professionally.
Is able to establish and maintain relations with people at all levels internally as well as externally and make people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills. Develops and maintains networks.