Regulatory Affairs Technical Lead
Regulatory Affairs Technical Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position
This senior individual contributor role in Regulatory Affairs will report to the Director of Regulatory Affairs and perform work for the Multiport da Vinci Surgical System business unit of Intuitive. This role will be focused on creating premarket submissions for the US market for the multiport da Vinci 5 Surgical System. There may be additional postmarket sustaining activities or other cross functional duties as they arise related to da Vinci 5 instruments and accessories or other Intuitive products. A total product life cycle (TPLC) model of work is expected. This role will serve as the RA Technical Lead in cross functional teams to bring new products to market. As a Professional 5 level role the person will serve as a subject matter expert and mentor for RA colleagues and core team members.
Essential Job Duties
- Having broad regulatory affairs expertise or unique knowledge uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Ability to lead departmental and cross functional projects and teams.
- Strong track record of leading strategic initiatives from concept through to completion; contributes to budget resource and financial planning for projects / programs; coaches and guides other colleagues in advancing their technical and business expertise.
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
- Exercises independent judgment in methods techniques and evaluation criteria for obtaining results.
- Creates formal networks involving coordination among groups.
- Consistently communicates effectively across varying organizational levels.
- Effectively takes the lead in communicating with and influencing senior stakeholders.
- Acts independently to determine methods and procedures on new or special assignments. May supervise activities of others.
- Independent. Can operate and drive results and set priorities with limited supervision.
- Effectively takes decisions and resolves issues that impact multiple teams and departments given the broad scope of responsibilities often involving complex strategies and high-level objectives.
Qualifications :
Required Skills and Experience
- Proven ability to professionally engage with and maintain positive relationships with regulatory agencies (e.g. FDA) with minimal supervision.
- Experience authoring 510(k) submissions and driving them through to clearance. Must provide a writing sample e.g. named Correspondent Contact on a cleared 510(k) listed on FDAs website with a posted 510(k) Summary.
- Experience authoring Pre-Submissions and holding meetings with FDA.
- Experience authoring Investigational Device Exemption (IDE) applications.
- Ability to understand review and provide feedback on engineering and other technical or clinical documentation to ensure scientific soundness technical accuracy and compliance to applicable rules regulations standards and guidance.
- Experience creating risk assessment documentation.
- Ability to interpret regulations and guidance for non-RA professionals.
- Flexibility and adaptability of thinking planning and strategy.
- Ability to influence stakeholders and to prioritize patient safety while meeting business needs.
- Ability to find solutions to complex problems.
- Proactive problem solver.
- Professional level of understanding of quality system regulations risk management and good documentation practices.
- Experience using FDAs eSTAR template and electronic submissions portal.
Required Education and Training
- Typically requires a minimum of 12 years of related experience with a STEM Bachelors degree; or minimum 8 years of experience and a Masters degree; or a PhD with minimum 5 years of experience; or equivalent experience.
Working Conditions
- Primarily an office environment. May be exposed to tissue animal or clinical labs.
Preferred Skills and Experience
- Regulatory Affairs Professional Certification for Medical Devices (RAC).
- Preparing OUS submissions
- Experience with robotic surgical systems or devices.
- Working knowledge of human anatomy and physiology.
- Working knowledge of soft tissue surgical procedures.
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 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.
Mandatory Notices
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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
