Principal Clinical Evaluation Specialist - Shockwave Medical

About the Role

Johnson & Johnson is seeking a Principal Clinical Evaluation Specialist to join the Shockwave Medical team. This fully remote position in the United States focuses on developing Clinical Evaluation Reports (CERs) and associated documents to support regulatory submissions for medical devices, particularly Intravascular Lithotripsy (IVL) technologies aimed at treating complex calcified cardiovascular disease.

Responsibilities

• Authors clinical documentation, primarily Clinical Evaluation Reports (CERs) and supporting documents such as Clinical Evaluation Plans (CEPs), Literature Search Protocols and Reports (LSPs/LSRs), and Post Market Clinical Follow-up (PMCF) Plans and Reports.
• Develops the clinical sections of regulatory submissions (e.g., CE Mark, PMA, IDE, 510K) and other technical documents as needed.
• Acquires and maintains knowledge of therapeutic areas, competitor devices, clinical/market developments, and literature review processes.
• Develops comprehensive literature search protocols and conducts in-depth literature searches to support CERs and other clinical evidence reports.
• Stays informed about applicable clinical landscapes and trends, providing product guidance to internal teams.
• Reviews, interprets, and summarizes scientific literature, including risks, alternative therapies, and device-specific benefits.
• Critically appraises scientific literature and writes clinical summaries for products and procedures.
• Manages CER timelines and project deliverables using appropriate project management tools.
• Collaborates with cross-functional teams to define strategies for CER development and regulatory submissions.
• Performs proofreading, editing, formatting, and review of documents for completion and approval.
• Conducts periodic reviews of risk documentation and product labeling to ensure updates are implemented.
• Provides clinical perspective to guide new product development for CE Mark and international registrations.
• Authors protocols and clinical study progress reports.
• Ensures compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP, US, and international guidelines).
• Supports other medical writing and scientific communication efforts (e.g., peer-reviewed publications, white papers, presentations) as requested.

Requirements

• Bachelor’s degree in a scientific or engineering field of study.
• 10 years of experience in medical devices, with at least 5 years of direct experience in CER writing.
• Expertise in medical device regulations, including MEDDEV 2.7.1, MDR, PMA, 510K, IDE, and Japanese regulations.
• Experience applying therapeutic and device knowledge to develop CERs.
• Strong experience in conducting literature searches, reviews, and appraisal of scientific data.
• Proven ability in protocol development, writing clinical sections for regulatory submissions, and clinical evaluation report writing.
• Ability to identify critical information needs and stakeholders in clinical evaluation development.
• Demonstrated ability to communicate effectively in technical or scientific writing, with excellent critical and analytical thinking skills.
• High level of attention to detail, accuracy, and organization.
• Ability to work effectively on cross-functional teams and manage multiple projects across disciplines.
• Strong communication, presentation, and interpersonal skills.

Skills

• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching and Collaboration
• Communication and Copy Editing
• Data Synthesis and Industry Analysis
• Medical Affairs and Medical Communications
• Problem Solving and Process Orientation
• Proofreading and Quality Standards
• Research Ethics and Standard Operating Procedure (SOP) compliance

Pay

The anticipated base pay range for this position is $125,000.00 - $201,250.00.

Benefits

• Retirement and Savings: Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Long-Term Incentive Program: Eligible to participate in the Company’s long-term incentive program.
• Time Off:
  • Vacation: 120 hours per calendar year.
  • Sick Time: 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents).
  • Holidays: 13 days per calendar year, including Floating Holidays.
  • Work, Personal, and Family Time: Up to 40 hours per calendar year.
  • Parental Leave: 480 hours within one year of birth/adoption/foster care of a child.
  • Bereavement Leave: 240 hours for an immediate family member, 40 hours for an extended family member per calendar year.
  • Caregiver Leave: 80 hours in a 52-week rolling period.
  • Volunteer Leave: 32 hours per calendar year.
  • Military Spouse Time-Off: 80 hours per calendar year.

For additional general information on Company benefits, visit Johnson & Johnson Employee Benefits.