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Sr Dir Regulatory Operations & Indirect Markets

Company: H&M Hennes & Mauritz GBC AB
Location: Sunnyvale
Posted on: February 25, 2021

Job Description:

Sr Dir Regulatory Operations & Indirect Markets At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique. As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges. We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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--help to advance the world of minimally invasive care. Primary Function of Position: This position will drive regulatory and quality directives for all indirect (distributor) regions as well as all the RA Ops team to support US, EU and APAC post submission work or changes. Establish and maintain requirements for indirect partners including processes, procedures, quality monitoring and thresholds for escalation as well as RA ops process, team and product management. Management of teams (at corporate and within direct regions) supporting regulatory submissions for product release to respective regions and alignment with the commercial team for timelines and goals. Oversight of indirect Quality Management System monitoring and audits including issuing findings and implementation of corrections. Overseas RA ops team in each region to support post submission as well as management of specific dossier in coordination with regional and corporate leaders being in charge of anticipating and providing global visibility of RA ops process when product change, facility change or any other type of changes occur. Ensure adequate resources are allocated for respective activities both for indirect and RA ops process support. Corporate point of contact for indirect accounts to support needs, provide alignment and ensure success from a regulatory and quality perspective. Roles and Responsibilities: This position has responsibility and authority for:

  • Align with indirect partners to ensure regulatory requirements are met and maintained
    • Determine ISI required processes and procedures
    • Create training plans and enforce
    • Review contractual agreements and requirements (update as needed)
    • Collaborate with indirect partners on needs and requirements
    • Regional regulation requirement alignment (new or existing)
    • Create and maintain regulatory submissions for product release to indirect regions
    • Manage and submit post submission dossier to support each regions
    • In charge of global GRA process and MCF post initial submission
    • Develop a network of contacts within distributors and ISI for successful collaboration, support and commununications as well as in Corporate team
    • Alignment with commercial team on goals and timleines for submissions realted to product launches and procedure volume for direct and indirect market needs.
    • Create and maintain a monitoring program for indirect partners (i.e. scorecard) to measure and report performance in the regulatory and quality space
    • Collaborate with internal ISI teams impacted by indirect performance, such as post market / field engineering / compliance and product support, to identify areas of required improvement and execute plans to correct pro-activley
    • Maintain indirect quality management system audit program to ensure alignment with regulatory requirements
      • Oversee quality management system audit findnigs and ensure successful implementation of corrections
      • Identify at risk indirect partners and develop action plans to support
      • Communications to indirect management teams as well as ISI management teams as necessary to ensure visibility and action
      • Alingment with internal ISI teams to ensure support and visibility to areas of concern prior to audit and post audit
      • Provide executive updates as needed on indirect partner performance and status
      • Participate in new indirect partner selection and integration
      • Determine level of regional support needed for indirect markets and ensure adequate resources are provided to support regulatory and quality initiatives
      • Drive and simplifify GRA post submission with business architechture process and team as well as with IT to ensure proper synergies with associated global process Skill/Job Requirements: Competency Requirements: (Competency is based on: education, training, skills and experience.) In order to adequately perform the responsibilities of this position the individual must:
        • Minimum of 10 years relevant experience within Quality Systems, Compliance or Regulatory
        • Firm understanding of global regulatory requirements
        • Capability of building strong relationships with global partners considering language and cultural differences
        • High capacity and ability to manage multiple teams, tasks, projects, and highly visibile and impactful assignments
        • Strong verbal and written communication skills
        • Exceptional interpersonal skills and excellent ability to work well with cross-functional teams
        • Excellent project management skills
        • Ability to manage various critical tasks and priorities successfully
        • Experience working with regulatory controlled agencies and environments
        • Ability to manage at multiple layers (up and down)
        • Experience and application of process implementations and improvements
        • Ability to translate regulatory requirements into task driven processes and procedures
        • Experience with external auditors (ie FDA, Competent Authorities, Notified Bodies) and ability to communicate processes and organization requirements
        • Minimum Bachelors degree or higher required
        • Minimum of 5+ years experience leading teams Intuitive is an Equal Employment Opportunity 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.--

Keywords: H&M Hennes & Mauritz GBC AB, Sunnyvale , Sr Dir Regulatory Operations & Indirect Markets, Other , Sunnyvale, California

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