JOB9899 Sr Director Global Regulatory Intelligence And Clinical Evidence Evaluation

The primary function of this role is to develop and expand our Global Regulatory Intelligence footprint and prepare the organization to gather intelligence on current and future regulations. This leader will be instrumental in shaping our standards adoption and integration strategy ensuring it meets commercial and regulatory requirements across an increasing number of global markets.

This position will lead crossfunctional reviews and assessments for new regulations or certifications as well as develop and drive internal regulatory clinical evidence strategies for CE marking and other regions. The role will support and oversee processes related to compliance with the EU Medical Device Regulation (EU MDR) and beyond including processes procedures quality monitoring and escalation thresholds. It will manage clinical evaluation planning PMCF processes CEP and new processes for realworld evidence to support regulatory submissions. This role will serve as the corporate point of contact for the EU Notified Body ensuring alignment and success from a regulatory EU clearance perspective.

This position oversees product indications and consolidation as well as the management of on and offlabel uses by region.

This highly visible leader will drive regulatory advertising and promotion (A&P) activities identifying and integrating regulatory and compliance requirements to facilitate materials review product communication and optimization of the A&P process while working closely with the marketing and clinical teams.

This leader will continue to build out processes to deliver insights and prepare the organization to meet current and future regulatory requirements applicable to our processes and product portfolio.

This position will lead crossfunctional reviews and assessments for all business units and product portfolio management associated with product launch documents. The individual will have a solid understanding of the complexities of the organizations regulatory processes critical information and how to simplify these processes while working closely with business partners.

by the VP Global RA and RAQA Commercial
o    Act if necessary as:
o    EU authorized representative contact for the EMEIA HQ organization and region (according to the EU MDD and moving forward MDR) per delegation from VP Global RA and RAQA Commercial
o    Management representative when delegation provided by VP Global RA and RAQA Commercial
o    Budget responsibility development in alignment with VP Global RA and RAQA Commercial and regional leads 
o    Could support country commercial organization development and implementation of country specific needs with proper teams 

Advertising and Promotion (A&P): 
o    Manage the full scope of the A&P process globally and its supporting personnel leading the A&P team related to all corporate document review related to marketing and any compliance discussion related to our product claims and intended use. 
o    Chair the A&P committee with the clinical and marketing team functions. 
o    Act as a primary source of expertise related to A&P materials within the organization reviewing all materials used for product communication or advertising.
o    Create and improve the maturity and compliance of Standard Operating Procedures (SOPs) templates forms and logs.
o    Liaise between incountry clinical marketing teams in the Direct and Indirect QARA groups Subject Matter Experts and Regulatory Affairs to facilitate completion of regulatory review of A&P. Incumbent will work closely with the local process owners and business partners to ensure procedures are followed and appropriate evidence/record is established to support audit readiness.
o    Work closely with other managers and leadership teams to better ascertain how A&P can improve forward looking regulatory requirements monitoring and provide inputs to the appropriate processes.
o    Develop relationships necessary to exchange data and information with other intelligence groups across Intuitive such as: GAVE Market Intelligence Competitive Intelligence and others as the need arises
o    Ensure that periodic updates are prepared as required by leadership and management forums (i.e. Quality Review Board (QRB) Regulatory Surveillance Operating Committee (RSOC) Management Review etc..   Compiles and reports process metrics and KPIs related to Veeva tool; provides periodic process timeliness reports to help keep assessment and Implementation activities ontarget.
o    Work closely with the global regulatory clinical and compliance organizations to fully understand applicable standards / regulations and implement processes to ensure Intuitive achieves and maintains compliance. 
o    Drive intelligence and communication of emerging regulatory trends and implications to internal stakeholders. 
o    Provide insights and direction to key internal stakeholders including but not limited to Clinical Evaluation Supply Chain Master Data Quality Regulatory Labeling Marketing and Product Development. 
o    Ensure business requirements are defined/captured in relationship to standards application and management within associated enterprise IT and master data architecture and design.

Qualifications :

• Expert knowledge of applicable rules regulations and guidance related to premarket submissions including clinical studies
• Expert knowledge of QSR
• Knowledge of technical standards and their use e.g. IEC ISO.
• Ability to effectively interact directly with regulators to achieve company goals
• Ability to build consensus and to negotiate a favorable position for the company
• RAC certification is a plus
• Experience working with professional or trade associations regionally and by country (eg Advamed BvMed Snitem

• Minimum of 10 years relevant experience within the total product lifecycle of medical devices
• Expertise interacting with regulatory agencies including leading meetings with regulatory agencies
• Proven track record of effective collaboration with regulatory agencies e.g. successful clearances and meeting deadlines for submissions in a least burdensome manner
• Expert knowledge of applicable regulatory requirements
• Capability of building strong relationships with internal and global partners considering language and cultural differences
• High capacity and ability to manage multiple teams various complex tasks and projects and highly visible and impactful assignments
• Strong verbal and written communication skills in English with multiple levels of leadership
• Exceptional interpersonal skills and excellent ability to work well with crossfunctional teams
• Experience and application of process implementations and improvements e.g. writing and implementing SOPs
• Ability to translate regulatory requirements into task driven processes and procedures
• Experience with external auditors or inspectors
• Ability to quickly read understand write and communicate complex technical and medical information e.g. engineering drawings test reports peerreviewed publications in clinical and engineering journals
• Bachelors degree in science engineering technology or mathematics (advanced degree preferred)
• Minimum of 10 years experience leading cross functional teams

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

EEO and AA Policy

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime