Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
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 cross-functional 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 real-world 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 off-label 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 cross-functional 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 organization’s regulatory processes, critical information, and how to simplify these processes while working closely with business partners.
CORE RESPONSIBILITIES:
Clinical Evidence Evaluation (CEE):
o Leading the overall process and strategy for the clinical evaluation plan (CEP) for existing products being remediated for MDR implementation and new products
o Develop and maintain the CEP process in compliance with the requirements of Annex XIV of the MDR and utilizing MDCG and MEDDEV 2.7/1 guidance.
o Create and maintain CEP(s) documents for existing products as part of ISI MDR Program and for new products as part of new product development teams.
o Engagement of Clinical Affairs, Product Management and GAVE groups as a major cross-functional stakeholder
o Leading the overall process and strategy for Post Market Clinical Follow Up (PMCF) for existing products being remediated for MDR implementation and new products.
o Develop and maintain the PMCF process in compliance with the requirements of Annex XIV of the MDR and utilizing MDCG guidance.
o Create and maintain PMCF Plans for existing products as part of ISI MDR Program and new products as part of new product development teams.
o Ensure PMCF commitments are tracked and executed, and PMCF data is evaluated and PMCF Evaluation Reports created per project plans.
o Driving overall CEP and PMCF processes in close collaboration with an internal ISI cross-functional team of subject matter experts, such as Clinical Affairs, Clinical Development Engineering, Risk Management, Post Market Surveillance, and Product Management to gather required information for the development evidence strategies and creation of CEP, PMCF and PMCF Evaluation Report.
o Providing guidance and direction to Regulatory Affairs associates in the documentation of both CEP and PMCF processes, as well as any new process development to support integration of clinical evidence (clinical investigations, PMCF studies, literature, real-world data) to support clinical evaluation and PMCF and other activities to achieve clearance of those products and/or indications for EU and other regions, as required.
o Providing strategic input for clinical study design and conduct including protocol development and study reporting for clinical studies supporting submissions.
o Alignment to develop and lead the global on-label assessment board and track representative uses or indications across our regions and commercial entities
o Promoting the integration of EU regulatory clinical evidence needs into global strategic evidence generation plans
Regulatory Intelligence and Strategy (RIS):
o RA intelligence, government intelligence, data process generation for reimbursement
o Identifying opportunities to improve processes and leading initiatives to implement solutions
o Representation of ISI in external organizations (e.g. MedTech Europe CI working group) as delegated 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 it’s 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 in-country 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 on-target.
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
CORE SKILLS & COMPETENCIES:
- 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 cross-functional 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, peer-reviewed publications in clinical and engineering journals
- Bachelor’s 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 COVID-19. 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.
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 market-competitive 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.
Base Salary Range Region 1: $244,000 USD - $366,000 USD
Base Salary Range Region 2: $207,400 USD - $311,200 USD
Shift: Day
Travel: 50% of the time
Workplace Type: Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.
