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 will head up the RA team focusing on the Blood Gas (BG) and Transcutaneous Monitors (TC) product areas. 6 specialists located at the HQ facility in Greater Copenhagen will be reporting to the role. The team supports all R&D projects within the areas of BG and TC and is responsible for supporting RA activities related to R&D projects, compliance, lifecycle management, improvement projects and working closely together with relevant stakeholders locally in Denmark as well as worldwide.
Consequently, the position calls for an experienced global RA executive with strong potential or a proven track record of strong 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.
Senior Director, RA
Responsibilities & Tasks:
Leading and managing a mixed team of experienced and less experiences 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).
Generating RA input and assessments in relation to change orders and building submissions & documentation to support these.
Interpreting regulations, standards & guidance documents, and providing input to the organization of such.
Participating in process improvements and creation of SOPs in the RA area.
Driving effective collaborations with R&D, Clinical & Medical Affairs, Marketing, and Sales to ensure that market and patient needs, and clinical trial objectives, remain a shared focus leading to scientifically robust and compliant strategies and product approvals.
Delegating initiatives and tasks, while managing timelines, budgets and resource allocation according to requirements of the business.
Ensuring strong performance of the RA team, including but not limited to compliance, audit preparation and completeness, growth initiatives, registrations, submissions etc.
Ensuring an effective working relationship with FDA, NMPA, Notified Body and other regulatory authorities on submissions and vigilance.
Ensuring talent and organizational development, and the achievement of departmental objectives.
Performing effective leadership to drive continuous improvement.
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 and a high-performance DBS, including excellent utilization of DBS tools, to build future RA muscle and ensuring that DBS is leading the way to sharpening focus on reaching the vison.
Successfully driving broad cross-functional stakeholder collaborations, alignment and communication.
Degree at M.Sc.-level within Science, Engineering, Pharmacy, Biology, Biochemistry or the like.
English – fluent (verbally and written).
Ideal experience and competencies:
Extensive experience in successfully leading within a global and dynamic environment, while driving team performance and championing organizational change.
Preferably 3-5 years of manager experience leading in a Global environment.
Strong RA knowledge and experience with medical device legislation (MD and/or IVD) on different markets worldwide e.g., EU, MDSAP countries, Korea and LATAM.
Extensive experience with Design control and RA activities related to this.
Well-versed with working in an environment with changing priorities daily.
Well-versed in setting the direction for a department/strategy and delegation and prioritization of tasks.
Preferably experience with continuous improvement tools and processes.
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.
Is service-minded; Focuses on the needs of stakeholders and on improving the service in realistic and efficient ways, values stakeholders and service highly.
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.