Regulatory Postmarket Specialist

4 weeks ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

The Regulatory Postmarket Specialist provides expertise and support for the development of post-market strategies, plans and reports for new and existing Intuitive products.  This individual will work with cross-functional teams in the development of post-market strategies and create documentation including the plans and reports (e.g. post-market clinical follow-up plans, periodic safety update reports), which support regulatory approvals and compliance.  The role will require close partnership with cross-functional teams including Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.

Essential Job Duties

  • Support the development of strategies that meet regulatory post-market requirements in collaboration with cross-functional teams.
  • Create regulatory post-market documentation such as PMCF Plans and PSURs.
  • Summarize data and use methods of data presentation that improve the quality and readability of reports and documentation.
  • Build relationships with key stakeholders and cross-functional partners including Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.
  • Apply working knowledge of European Union Medical Device Regulation (MDR) to guide project teams through the regulatory postmarket requirements.
  • Demonstrate good judgement for obtaining solutions.
  • Work to balance priorities and drive results with some supervision.
  • Facilitate effective team collaboration by leading meetings, using software tools (e.g. Zoom, Box, Sharepoint), and developing dashboards and other communication tools.
  • Draft and assemble documentation as required for internal records and regulatory submissions.
  • File documentation in systems such as Agile.
  • Participate in process improvement activities to continuously improve process effectiveness.
  • Other tasks and projects may be assigned as necessary.

  • Regulatory Postmarket Specialist

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionThe Regulatory Postmarket Specialist provides expertise and support for the development of post-market strategies, plans and reports for new and existing Intuitive products. This individual will work with cross-functional teams in the development of post-market strategies and create documentation including the plans and reports (e.g....

  • Materials Regulatory Compliance Specialist

    2 weeks ago

    Sunnyvale, United States META Full time

    The Material regulatory compliance (MRC) specialist within the RL Quality and Compliance team will lead and champion MRC compliance across RL products. Candidate is expected to have demonstrated skills in collecting full material disclosures, has a strong background in material regulations for consumer electronics and environmental compliance requirements,...

  • Sr. Regulatory Affairs Specialist

    1 week ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted accurately, ethically based upon the latest relevant regulations and standards, so that regulatory compliance...

  • Sr. Regulatory Affairs Specialist

    6 days ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted accurately, ethically based upon the latest relevant regulations and standards, so that regulatory compliance...

  • Environmental Compliance Specialist

    7 days ago

    Sunnyvale, United States Kelly Full time

    Position: Environmental Compliance SpecialistType: Contract (6 Months)Shift: Day Shift, M-FLocation: Sunnyvale, CA (Hybrid)Hourly Pay Range: $38 to $45/hour (Based on Experience)Kelly Engineering is actively seeking a Environmental Compliance Specialist to join our client, a leader in the medical device industry. The Environmental Compliance Specialist is...

  • Environmental Compliance Specialist

    3 weeks ago

    Sunnyvale, United States Kelly Full time

    Position: Environmental Compliance SpecialistType: Contract (6 Months)Shift: Day Shift, M-FLocation: Sunnyvale, CA (Hybrid)Hourly Pay Range: $38 to $45/hour (Based on Experience)Kelly Engineering is actively seeking a Environmental Compliance Specialist to join our client, a leader in the medical device industry. The Environmental Compliance Specialist is...

  • Environmental Compliance Specialist

    3 weeks ago

    Sunnyvale, United States Kelly Full time

    Position: Environmental Compliance SpecialistType: Contract (6 Months)Shift: Day Shift, M-FLocation: Sunnyvale, CA (Hybrid)Hourly Pay Range: $38 to $45/hour (Based on Experience)Kelly Engineering is actively seeking a Environmental Compliance Specialist to join our client, a leader in the medical device industry. The Environmental Compliance Specialist is...

  • Environmental Compliance Engineer

    2 weeks ago

    Sunnyvale, United States Kelly Services, Inc. Full time

    Position: Environmental Compliance Specialist Type: Contract (6 Months) Shift: Day Shift, M-F Location: Sunnyvale, CA (Hybrid) Hourly Pay Range: $38 to $45/hour (Based on Experience) Kelly Engineering is actively seeking a Environmental Compliance Sp Environmental, Compliance, Engineer, Compliance Specialist, Regulatory Affairs, Staffing

  • Automation Specialist

    2 weeks ago

    Sunnyvale, United States Ascend Clinical Full time

    Job DescriptionJob DescriptionAutomation SpecialistLocations: Sunnyvale, CAWhy Ascend?Come work for a company that is transforming the industry!We are Ascend, one of the highest volume clinical laboratories in the United States. With the use of the most advanced tools and technology, we process millions of tests each month. For over 30 years, we have been...

  • Clinical Affairs Specialist 3

    2 weeks ago

    Sunnyvale, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThis position reports to the Manager, Clinical Affairs, Advertising & Promotion (A&P) Review and is mainly responsible for reviewing A&P material for conformance to known clinical evidence landscape and applicable A&P guidelines and regulations, with potential for future additional clinical responsibilities...

  • Clinical Affairs Specialist 3

    3 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThis position reports to the Manager, Clinical Affairs, Advertising & Promotion (A&P) Review and is mainly responsible for reviewing A&P material for conformance to known clinical evidence landscape and applicable A&P guidelines and regulations, with potential for future additional clinical responsibilities...

  • Clinical Affairs Specialist 3

    2 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of PositionThis position reports to the Manager, Clinical Affairs, Advertising & Promotion (A&P) Review and is mainly responsible for reviewing A&P material for conformance to known clinical evidence landscape and applicable A&P guidelines and regulations, with potential for future additional clinical responsibilities...

  • Mgr Customer Learning and Development, Digital Products

    4 weeks ago

    Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:The Manager, Customer Learning & Development (CLD) will manage a team responsible for content development by partnering with internal teams and stakeholders to identify training needs and design/ develop curriculum to effectively train our internal and external customers. They will support their team to manage...

  • Product Manager

    3 weeks ago

    Sunnyvale, United States LanceSoft Full time

    Product Manager Specialist -Material Master Management How will you make an impact? We are looking for a detail-oriented individual who enjoys defining and improving processes to support the entire IC/SP product management team through maintenance and evaluation of master data. The role will provide opportunities to be exposed to all parts of the product...

  • Document Control Analyst III

    2 weeks ago

    Sunnyvale, United States Tailored Management Full time

    Document Control Analyst Job ID: 52548-1 Competitive Pay Rate: Location-based pproved Locations: 100% onsite; Sunnyvale, CA Duration: Initial 12-month contract; extensions/conversion based on performance Start: Targeting May 2024 Benefits: Medical, dental, vision, disability + PTO & sick time available Job Description: The Document Control...

  • Document Control Analyst III

    3 days ago

    Sunnyvale, United States Tailored Management Full time

    Document Control Analyst Job ID: 52548-1 Competitive Pay Rate: Location-based pproved Locations: 100% onsite; Sunnyvale, CA Duration: Initial 12-month contract; extensions/conversion based on performance Start: Targeting May 2024 Benefits: Medical, dental, vision, disability + PTO & sick time available Job Description: The Document Control...