SENIOR RA MANAGER
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.
In the role, you will be leading a team of four team members and be overall responsible for market approvals within a growing product area. Focus will be on supporting development projects (primarily) and maintenance projects (secondarily) and to ensure adequate resources for execution and that the team is flexible, delivers on time and thrives.
The position has a seat in the global RA management team and calls for a strong RA professional with management experience and succession planning potential, combined with a strong drive and motivation for leadership. You will also, once settled in the role, take over the seat in the cross-functional leadership team for the business unit.
Senior RA Specialist
Greater Copenhagen, Denmark.
15-20 days per year
Responsibilities & Tasks:
Managing and leading the global RA team for the designated product area, currently consisting of four team members.
Ensuring and providing regulatory support to cross-functional development projects (primarily) and maintenance projects (secondarily) with special focus on the Immunoassay area with the view to obtain market approvals and regulatory compliance.
Participating in the global RA management team and contributing to efficient cross-organizational collaboration and engagement, and a well-functioning RA organization.
Interpreting legislation and ensuring on-time compliant implementation and delivery.
Driving process improvements and creating SOP’s in the RA area to maintain a lean organization.
Ensuring adequate resource allocation among team members and tasks, while contributing to the continuous development of each team member.
Cooperating with R&D, QA, Production, Sales and Marketing and other departments and stakeholders.
Key success criteria:
Successful development and implementation of a sound global regulatory strategy for the registration of the designated productportfolio.
Set the team designated to support a major new platform project.
Successful team management and leadership resulting in engaged and high-performing employees – reflected in strong engagement survey results.
B.Sc./M.Sc./Ph.D. degree in science, engineering, pharmacy, medical, biology, biochemistry or similar.
English – fluent verbally and in writing.
Ideal experience and competencies:
Strong RA experience – preferably from an IVD or Medical Device setting, or alternatively, from a pharma setting – including sound legislative knowledge.
Sound people management experience.
Sound cross-organizational collaboration and project management experience.
Preferably experience from working in a global/international setting – or alternatively, a regional/local setting.
Preferably experience from working in a RA setting supporting R&D and cross-functional projects.
Proven track record of compiling regulatory files and achieving approvals worldwide.
Preferably experience from a Kaizen/LEAN/ continuous improvement -minded setting.
Experience from working within/across different cultures.
Experience in working in cross functional projects.
Experience from working with MS Office and potentially with databases and Adobe Acrobat Pro.
Is naturally self-confident, reliable and able to push decisions through, while withstanding adverse conditions. Is sturdy and stress tolerant and keeps momentum during busy times with high demands and tight deadlines. Is flexible and can adapt to changing circumstances. Inspires others and encourages the achievement of set goals by promoting a sense of purpose and demonstrates strong drive, stamina, natural authority, and responsibility, while prompting a strong wish to succeed within the team.
Communicates effectively and in a clear, fluent and precise manner – always with minor preparation. Is able to keep the recipients' attention, while remaining attentive to the needs of others when he/she speaks. Produces written material, which is clear, fluent, precise and easy to understand for the recipients.
Exercises an analytical mindset and the ability to understand the underlying technical principle of products in the area of responsibility. Divides problems into relevant parts and differentiates between key areas and irrelevant and less important areas. Possess a logical mind-set and makes sensible decisions based on available information.
Is proactive, decisive, reliable and capable of performing own actions and initiatives without hesitation based on sound judgement.
Is positive and open-minded adding energy to the team by taking responsibility, while remaining engaged and committed to one’s responsibilities. Collaborates and works well with others with a view to obtain the team's objectives. Shares information and supports others.
Applies critical thinking and makes rational, realistic and sound decisions based on the involvement of available facts and possibilities.
Results and goal orientation
Focuses on targets and results and works well independently and in teams. Establishes visible and achievable goals for the department and focuses on action, activities and results. Is able to continue working at a specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed.