Position       : Senior Manager, EU MDR/IVDR

Location : Franklin Lakes, NJ

Duration : 12 Months Contract

Total Hours/week :40.00

Description:

• The Senior Manager, EU MDR/IVDR, Medical Governance and Analytics, will drive strategy for managing the Medical Affairs approach to compliance with EU MDR/IVDR including creating department policies, procedures and work instructions in order to facilitate consistent enterprise wide processes for EU MDR/IVDR. In addition, the role will lead the creation a governance model for this work to ensure compliance with the Medical and Clinical activities related to EU MDR/IVDR. This role will lead a network Medical Affairs/Clinical team from across the business.
• This team will serve as the network to ensure the procedures and processes can be leveraged across the businesses, share learnings from business experience with Notified bodies and share best practices. In addition, this role will serve as a liaison to other cross-function teams working on EU MDR/IVDR.
• This role will also be responsible to seek and create opportunities for efficiency for delivering Medical Affairs processes for EU MDR/IVDR.

• As well as being an expert in EU MDR/IVDR, the incumbent will be expected and to collaborate with other functional and cross-function associates working on compliance with EU MDR/IVDR.
• The role will collaborate with parts of the Global Medical Safety organization as well as Regulatory and Quality to ensure smooth and complete alignment of processes related to EU MDR/IVDR adverse event reporting and other EU MDR/IVDR safety activities.

Primary Accountabilities:

• The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive.
• The omission of a specific duty or responsibility will not preclude it from the position:

• Create a framework and strategy for key Medical Affairs and Medical Safety aspects to be compliant with EU MDR/IVDR and execution of key areas where a central model would create efficiency
• Integrate/create a set of control structures for Medical/Clinical EU MDR/IVDR activities including processes, procedures and associated accountabilities to ensure consistent governance and quality assurance.
• Serve as a liaison to cross-functional/cross-business EU MDR/IVDR working teams to ensure appropriate Medical Affairs/Clinical representation on those teams as well as appropriate feedback to the functional activities related to EU MDR/IVDR.
• Partner with Quality and Regulatory to ensure clear and appropriate alignment of processes for adverse event reporting for EU MDR/IVDR
• Work cross functionally/business unit (BU) to develop the Medical Safety Review Board (MSRB), which will be designed for safety signal detection review. This includes developing, gathering, managing and analyzing key safety KPIs, creating process flows and developing the MSRB content/material.
• Effectively communicate EU MDR/IVDR departmental strategy, metrics, and project status expectations with team members, stakeholders and Sr. Management in a timely and professional manner.
• Identify opportunities for efficient work practices and continuous improvement that would support the business unit Medical/Clinical EU MDR/IVDR work (i.e. identify and manage vendor for literature searches).

Position Qualifications:

• Strong leadership and influence management skills and the ability to function effectively and sensitively in large, highly-matrixed organization.
• Excellent analytical and problem solving skills.
• Deep understanding of and experience in EU MDR/IVDR preparedness.
• Deep understanding of the commercial and R&D organizations and how Medical/Clinical spans and supports these organizations.
• Strong knowledge of the global regulatory environment for medical devices and IVDs.
• Demonstrated learning agility within the healthcare industry
• Proven track record of being able to streamline the environment through highly efficient and scalable procedures/processes to enable successful execution on business priorities.
• Track record in providing high degree of reliance, accountability, and value-added consultation/support to business managers and other support functions.
• Ability to provide strategic advice as well as operational solutions.
• Ability to innovate and implement fit for purpose solutions.
• Strong problem-solving skills that are pragmatic
• Strong interpersonal skills with the ability to influence and communicate with individuals at all levels in an organization.
• Working knowledge of risk management principles and ability to translate theory into practice.
• Experience in project management of complex, cross-functional initiatives.
• Leadership:Proven ability to earn the trust of leaders within the organization, including senior leaders

• Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives
• Proven ability to resolve conflict (striving for win-win outcomes)
• Proven ability to deliver tough messages in a professional manner
• Proven ability to act independently and to execute with limited information and ambiguity

Education and/or Experience:

• Education in a Technical or Medical Science discipline, or other related field, or equivalent work experience
• 4+ years of management experience, with experience in a leadership type role within a highly matrixed environment
• Strong communication and influence management skills required;
• Proven track record of implementing change and driving efficiency and cost improvements;

Critical Competency Areas

• Strong sense of urgency and a desire to roll up his/her sleeves to do the work.
• Thorough understanding of all stages of medical device and/or In Vitro diagnostics product development and market introduction.
• Experience interfacing with regulatory bodies including the FDA, European notified bodies.
• Excellent written and verbal communications skills.
• Ability to travel frequently domestically and internationally.
• Proven ability to build, manage and lead globally distributed, large, strategic and/or complex teams
• Strong change management, leadership, and communication skills.
• Sets the relevant goals and milestones to drive the progress of projects; acts to surpass goals.
• Practice-level knowledge of project planning and management processes and best practices
• Team and organizational leadership
• Customer Focus
• Stakeholder engagement and relationship management
• Cross-functional collaboration and influence
• Operational and financial management
• Strong business and financial acumen (driving best value through projects)
• Interpersonal effectiveness (EQ, communications, conflict resolution)
• Critical thinking and decision making.
• Talent development (incl. mentoring/coaching)
• Specialized Knowledge Areas
• Medical Device and/or Life Sciences industry trends and market environment
• Medical Device and/or Life Science product development and commercialization
• Metrics development and implementation
• Project governance and facilitation
• Strategic alliance/partner management (co-development)