SENIOR DIRECTOR, RA
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 Sr. Director, RA will assume full responsibility and leadership of the global RA function and team of dedicated RA leaders and professionals at our vlient and contribute significantly to the sharpening of the future RA organization, navigating people, business and customer needs. In addition to the line management responsibility of approx. 6 direct reports and 35 FTE’s, the position will be responsible for all aspects of Regulatory Affairs at our client, while taking a seat in the Global RA/QA Leadership team.
Consequently, the position calls for a senior and highly experience global RA executive with a proven track record of strong organizational leadership, experience and interest in leading multiple layers and building effective teams in the medical device/IVD industry. Moreover, the ideal candidate has demonstrable successor capabilities.
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.
Senior Director, RA
30-35 days p.a.
Responsibilities & Tasks:
Developing and implementing strategies and plans to meet performance objectives of global RA and ensure development of the organizational set-up.
Developing employees through continuous development planning and driving successful and measurable employee engagement.
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 organization, 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.
Participating actively in steering groups and in the deployment of strategic cross departmental projects.
Ensuring talent and organizational development, and the achievement of departmental objectives.
Key success criteria:
Ensuring strong performance of the global RA organization with specific focus towards internal and external audits measured on non-conformities.
Securing country specific registrations according to business needs and successful preparation and leading of negotiations with RA authorities.
Ensuring timely delivery on projects and managing resource allocation and task delegation successfully.
Delivering high workplace assessments and Engagement Index scores.
Successfully driving broad cross-functional stakeholder collaborations, alignment and communication.
Degree at M.Sc.-level within Science, Engineering, Medical or Technical field.
English or Danish fluently in speech and writing.
Ideal experience and competencies:
Extensive experience in successfully leading within a global and dynamic environment, while driving team performance and championing organizational change.
+10 years' professional experience with increasing responsibility in IVD/Medical Device RA, including demonstrated success as leader of an RA or QA/RA complex business unit.
+8 years’ people leadership experience, including managing a large team across multiple global sites.
Profound experience with regulatory strategies, 510k clearances and other regulatory approvals, alongside international audits and regulatory authority negotiation experience.
Technically adept understanding of the IVD/Medical Device market and associated technologies.
In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and MDD).
Preferably proven track record with problem solving and continuous improvements.
Defines a clear vision and looks beyond and immediate difficulties to focuses on long-term objectives and consequences. View things in a broad perspective and takes environmental circumstances into account when planning and developing strategies.
Makes a good first impression and displays a high degree of empathy, trustworthiness, confidence and sturdiness inspiring trust and honesty.
Performs superior leadership in global and dynamic contexts, with strong focus towards relationship building and management, alongside the attraction, recruitment and development of human capabilities in the team.
Is proactive, inspire others and is able to take own initiatives without hesitation, while actively seeking influence and commence activities on own initiative.
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.
Customer and service awareness
Listen and responds to customer needs, while giving advice, following up, and continuously seeking new ways to improve.
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.
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.