Senior Staff Clinical Evaluation Specialist (Remote)

Stryker Corporation

Portage (MI)

Remote

USD 132,000 - 238,000

Full time

2 days ago
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Job summary

Stryker Corporation in the United States seeks a Senior Staff Clinical Evaluation Specialist to lead clinical evidence strategies for Surgical Technologies. The role is remote with residency in Eastern/Central time zones to align with team hours.

You will manage clinical evaluation projects, author evaluations and reports, and collaborate with regulatory and commercial teams to ensure compliant, evidence-based product development and lifecycle management.

Qualifications

  • Master's degree in a health/clinical/biological science or engineering field is required.
  • Doctoral degree (PhD/ PharmD/ MD or equivalent) is preferred.
  • Minimum 6 years in clinical affairs, regulatory, quality, medical writing, or related medical device functions.
  • Minimum 2 years authoring clinical evaluations for medical devices.

Responsibilities

  • Lead clinical evidence strategies for new products and lifecycle management.
  • Manage clinical evaluation projects aligning evidence, regulatory strategy, claims and commercialization.
  • Author and maintain clinical evaluations, post-market reports and regulatory submissions.
  • Design literature reviews, evaluate evidence, and synthesize data into conclusions.
  • Assess benefit-risk and develop evidence-based regulatory recommendations.
  • Collaborate with regulatory authorities and internal stakeholders on evidence needs.
  • Develop scientific communications such as manuscripts, abstracts, presentations.
  • Mentor teammates and improve evaluation methodologies and processes.

Skills

Fluent English

Education

Master of Science in health/clinical/biological science/biomedical/engineering or related field
Doctoral degree (PhD, PharmD, MD, or equivalent)

Job description

Work Flexibility: Remote or Hybrid or Onsite Stryker is hiring a Senior Staff Clinical Evaluation Specialist for our Surgical Technologies business unit. This is a remote position within the United States. To align with team collaboration and business operating hours, candidates must reside in the Eastern or Central time zones.

What You Will Do
  • Lead the development and execution of clinical evidence strategies for new product development and lifecycle management activities.
  • Manage clinical evaluation projects, ensuring alignment between clinical evidence, regulatory strategy, product claims, and commercialization objectives.
  • Author and maintain clinical evaluations, post-market clinical follow-up reports, safety and performance summaries, regulatory submissions, annual reports, and other clinical documentation.
  • Design and execute systematic literature reviews, evaluate published evidence, and synthesize clinical, preclinical, and post-market data into scientifically supported conclusions.
  • Assess benefit-risk profiles of medical devices and develop evidence-based recommendations in accordance with global regulatory requirements.
  • Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements and support regulatory submissions.
  • Develop scientific communications, including manuscripts, conference abstracts, presentations, white papers, and customer-facing evidence materials.
  • Mentor team members, lead cross-functional review processes, and identify opportunities to improve clinical evaluation methodologies, documentation practices, and team efficiency.
What You Need
  • Required Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related scientific field.
  • Minimum 6 years of experience in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, post-market surveillance, or related medical device functions.
  • Minimum 2 years of experience authoring clinical evaluations for medical devices.
  • Experience conducting literature reviews, evidence synthesis, and scientific analysis using clinical and technical data.
  • Experience supporting regulatory submissions and product lifecycle activities within a regulated healthcare industry.
  • Fluency in English.
  • Preferred Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related discipline.
  • Experience supporting global medical device regulatory requirements, including clinical evaluation, post-market surveillance, and market access activities.
  • Experience developing scientific publications, conference presentations, and clinical evidence communication strategies.
  • Experience managing complex cross-functional projects within the medical device industry.
United States of America Pay Ranges:
  • USN: $110,100 - $183,400 USD Annual
  • US5: $115,600 - $192,600 USD Annual
  • US10: $121,100 - $201,700 USD Annual
  • US15: $126,600 - $210,900 USD Annual
  • US20: $132,100 - $220,100 USD Annual
  • US30: $143,100 - $238,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

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