Senior Director, Global RA

Greater Copenhagen, Denmark

BRIEF COMPANY PROFILE
Our client is a leading provider of technologically advanced Medical Device/IVD 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, including oxygen, lactate, and troponin. 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. Culture – Integrity & Compliance Our client’s commitment to integrity and their reputation for fairness and honesty are the foundation for their continued success. The company insists that employees conduct business ethically and in full compliance with all applicable laws and Standards of Conduct (SOC), operating policies, and procedures. Being part of a Fortune 500 Group, acting with integrity is a necessary foundation for personal success and the Groups collective success. Building and sustaining a strong culture of integrity and compliance is critical to building a premier global enterprise. A culture of integrity and compliance provides a clear competitive advantage for the Group. Corporate Social Responsibility (CSR) Our client is dedicated to making a positive and socially responsible contribution in all of the +130 countries that they operate in. This CSR strategy entails a strong focus on issues of improving health and safety, recycling, the environment, and the very fabric that binds their business together: people. Acknowledging that people make a difference, our client has embraced new initiatives that include in-job training, i.e. Advanced Lean Education, and technical training programs, all to ensure that employees develop and expand their knowledge and skills on a continuous basis. In addition, our client has a strong focus on fostering talents, which generates good career opportunities across the Group.

THE POSITION
The Position 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 client and contribute significantly to sharpening the future RA organization, navigating people, business and customer needs. In addition to the line management responsibility of approx. 7 direct reports and 50 regulatory professionals, 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. The role will work closely with cross-functional teams to develop and execute regulatory strategies that support our client’s business objectives. Hence, the role will be accountable for the performance and results of the RA organization, including compliance, audit preparation and completeness, and growth initiatives such as registrations and submissions. Consequently, the position calls for a senior, highly experienced RA executive of international caliber, preferably from the MedTech/IVD space, with a proven track record of strong organizational leadership and RA subject matter expertise, particularly within FDA regulatory requirements. The ideal candidate displays a visionary approach, customer focus and a strong commitment to quality and compliance. Moreover, the candidate is organized and structured with high initiative, self-motivation and energy. Finally, the ideal candidate possesses demonstrable VP-successor capabilities.

POSITION PROFILE
Position title:	Sr. Director, Global RA.

Reporting line:	Vice President, Global RA/QA.

Reporting to the position:	Approx. 7 direct reports and 50 FTE’s altogether.

Location:	Greater Copenhagen.

Traveling:	30-35 days p.a.

Responsibilities & Tasks:	Developing and implementing regulatory strategies for successful product approvals. Developing employees through continuous development planning and driving successful and measurable employee engagement. Driving effective collaborations with key internal stakeholders in R&D, Manufacturing, 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. Building and maintaining strong relationships with key external stakeholders, including regulatory agencies, industry associations, and other external partners, to partner for impact. Identifying and communicating potential regulatory risks to executive management. Delegating initiatives and tasks while managing timelines, budgets and resource allocation according to the business requirements. 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 regarding submissions and vigilance. Participating actively in steering groups and in the deployment of strategic cross-departmental projects. Ensuring talent and organizational development, and achievement of departmental objectives. Performing effective leadership through tools to drive continuous improvement.

Key success criteria:	Ensuring strong performance of the global RA organization with a 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 of projects and managing resource allocation and task delegation successfully. Delivering high workplace assessments, retention and Engagement Index- and Talent Management scores. Successfully driving a high-performance continuous improvement (CI) mindset, including excellent utilization of CI tools, to build future RA muscle and ensuring that CI is leading the way to sharpening focus on reaching the vision. Successfully driving broad cross-functional stakeholder collaborations, alignment and communication.

CANDIDATE PROFILE
Educational background:	Master's degree or PhD in a science, engineering, medical, or technical field.

Language:	English fluently in speech and writing.

Ideal experience:	Long-standing professional expertise in medical device regulatory affairs, including leadership of QA/RA or regulatory affairs for a complex business unit. Proven track record of successful regulatory strategies, clearances, and approvals, including experience with international audits and negotiations with regulators. In-depth knowledge of FDA regulations, guidelines, and submissions. Well-versed in relevant standards and regulations in Canada, Asia, Europe and other key markets (ISO, IVDR and MDR). Updated on changes to regulations, standards and guidelines worldwide, as well as industry trends and best practices. Multiple years of people leadership experience, including managing a large team across multiple global sites. Profound international audit and regulatory authority negotiation experience. Preferably proven track record with problem-solving and continuous improvements.

Personal & leadership competencies:	Visionary Defines a clear vision and looks beyond immediate difficulties to focus on long-term objectives and consequences. Views things from a broad perspective and takes environmental circumstances into account when planning and developing regulatory strategies. Initiative Is proactive, inspires others and is able to take own initiatives without hesitation while actively seeking influence and commencing activities on own initiative. Customer focus  Listens and responds to customer needs while giving advice and following up. Assertive  Creates followership and makes things happen; willing to make decisions while leading through influence. Take control/responsibility Makes sure employees have a clear understanding of the direction of the tasks; expects employees to offer solutions to problems. Global leadership  Performs superior leadership in global and dynamic contexts, with a strong focus on relationship building and management, alongside the attraction, recruitment, and development of human capabilities in the team. Team orientation Collaborates and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information. Communication Communicates the central issues in a discussion in a clear, fluent and precise manner, is able to keep the recipients' attention, attentive to the needs of others when he/she speaks. Produces written material, that is clear, fluent, precise and easy to understand. Integrity Builds a 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.

Senior Director, Global RA

BRIEF COMPANY PROFILE

THE POSITION

POSITION PROFILE

CANDIDATE PROFILE

Share this opportunity