10 days old

Clinical Evaluation Specialist III

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
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
Primary Function of Position:

This position reports to Sr.Manager, Clinical Affairs, (Clinical Evaluation) and requires a strong candidate with experience in medical writing of clinical regulatory documents. The position will mainly focus on development of Clinical Evaluation Reports (CERs), with potential for future additional responsibility for development of other clinical evidence documents. The purpose of this job is to author and develop clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance.

Roles and Responsibilities:

  • This position has responsibility and authority for:
  • Authoring Clinical documentation mainly the Clinical Evaluation Reports (CER) including clinical section of regulatory authority requests.
  • Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
  • Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends.
  • Providing product guidance to the clinical librarian to help with conducting literature searches on products/product families.
  • Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
  • Critically appraise scientific literature and write clinical summaries for products and surgical procedures
  • Managing CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
  • Serve as a functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and will support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses..
  • Interacting with internal teams (engineering/product development/regulatory) to define the plan and strategy for development of the Clinical evaluation reports for new products requiring CE Mark.
  • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
  • Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
  • Provide clinical perspective and support to guide new product development for CE Mark purposes. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input.
  • May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on Intuitive clinical trials.
  • May author Protocols and/or routine Clinical Study Progress Reports.
  • Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)
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:

  • Previous experience in the application of therapeutic and device knowledge to development of clinical evaluation reports.
  • Must have a minimum of 2-4 years of medical writing experience
  • Minimum of 0-2 years of experience in clinical evaluation report writing in a medical device industry is preferred.
  • Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development.
  • Strong experience in conducting literature searches, reviews and appraisal of the scientific data.
  • Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.
  • Excellent critical and analytical thinking skills.
  • MD, PhD or M.S. degree in scientific field is desired.
  • Must have high level of attention to detail and accuracy.
  • Must be able to work effectively on cross-functional teams.
  • Must be able to manage multiple projects across numerous surgical disciplines.
  • Strong communication, presentation and interpersonal skills with high attention to detail and organization.
  • Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing.
  • Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
  • Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary

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 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.

Shift : Day

Travel : 10% of the time

Posted: 2022-08-02 Expires: 2022-08-31
Sponsored by:
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Sponsored by:
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Clinical Evaluation Specialist III

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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