Primary Function of Position :
The Director Regulatory Affairs Digital Solutions develops and drives regulatory clearance strategies and processes for global digital solutions with a focus on digital medical devices and supporting applications.
Roles and Responsibilities :
Main activities
Develop implement and execute regulatory strategies that enable interconnected devices deployment in a global environment
Assure timely regulatory clearances for key digital solution launches in US and Canadian markets; Drive for inclusive approach to global digital regulations to support commercial strategiesExercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manage oversee and balance resource allocation across critical projects;Regulatory Agencies & advocacyPrepare the organization for continuous regulation changes and streamline processes to adapt to rapid product development
Represent Intuitive in key interactions with regulatory agencies to build a strong and trusted relationshipFollowup with organizations committees and task force meetings with the aim of developing Intuitive positions and actively contributing to achieve desired policy outcomesIdentify potential partners (industry think tanks etc.) or relevant stakeholders for Intuitives positions and advocacy involvementProcessTranslate regulations into actionable processes and requirements
Identify and lead process improvement effortsEnsure that company policies procedures and practices are in compliance with applicable regulatory requirementsPeople ManagementAssesses the current state of the department (organizational structure competencies and skills) and implement a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
Leverage expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative resultsIdentify competences and skills necessary to support regulatory strategies and company goalsLead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive mannerDeliver by mobilizing and inspiring an accountable team to deliver results for ontime clearances with a global and enterprisewide mindset and balance with strategic and shortterm goalsAdditional activities
Other regulatory tasks and projects may be assigned as necessaryTravel : up to 20%Qualifications :
Required Knowledge Skills and Experience :
At least 12 years of significant experience in regulatory affairs for medical devicesMinimum a Bachelors or Masters degree in engineering medical technology or similar preferred (or equivalent work experience in similar function)Comprehensive knowledge of device development processExpert knowledge of appropriate global medical device regulations requirements and standards such as 21 CFR 800 European Medical Device Regulation (2017 / 745 / EU)Knowledge of product regulations (eg wireless electronical safety ROHS)Senior leadership experience is required including line management of multiple levels of reporting.Strong analytical skills and problemsolving ability including the ability to make complex decisions and willingness to defend difficult position.Demonstrate good interpersonal skills ability to work with others in international team environment effective interactions in cross department teams.Ability to lead and influence project teams committees etc. to meet project goals and to drive changes.Ability to be effective in complex projects with ambiguity and / or rapid changeFluent in written and spoken EnglishGeneral Computer literacy (PC Microsoft Word / Excel / PowerPoint Outlook)Preferred Knowledge Skills and Experience :
RAC certification is a plusExperience with digital technologiesExperience with novel technologies (AI and machine learning)Experience working with professional or trade associationsAdditional 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 : Employment Type :
Fulltime
