Specialist, Clinical Development

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Benefits offered by this job

Benefits programs

Job summary

Edwards Lifesciences is seeking a clinical affairs professional to drive integration of clinical input into multiple product development projects for transcatheter heart valve therapies. You will design pre-clinical test strategies, perform first-in-man evaluations, and prepare essential clinical documentation to support regulatory approvals.

The role involves cross-functional collaboration to ensure alignment with GLP/GCP practices and regulatory requirements, while advancing patient outcomes

Qualifications

• Bachelor's degree required in biological or life sciences; 3 years in medical device or clinical studies preferred.
• Strong proficiency in MS Office and document management tools; excellent written/verbal communication.

Responsibilities

• Ensure clinical input is included in product development for patient/physician benefit.
• Develop and implement pre-clinical test strategy and guide execution.
• Conduct first-in-man evaluations and provide case support for proper use.
• Create and justify Clinical Investigator Brochure and clinical documentation.
• Provide regulatory- and clinical-compliance guidance for site/country approvals.
• Support field trial managers with device performance feedback and regulatory adherence.
• Manage literature reviews for design concept and clinical evaluation reports.

Education

Bachelor's Degree in biological or Lifesciences

Bachelor's Degree in engineering

Tools

MS Office Suite

Adobe

Ignite (documentation management system)

Job description

We’rededicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies thatimpactpatient outcomes and quality of life.We’reworking together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us and be part of our inspiring journey.

How you'll make an impact:

• Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.
• Ensure successful product lifecycle management for multiple projects, including:
• Develop and implement pre-clinical test strategy and provide guidance to team members on strategy execution
• Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
• Create Clinical Investigator Brochure
• Provide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvals
• Provide product expertise for new product introduction training for clinical and site personnel
• Design, develop, conduct, and assess results of post-market evaluations
• Develop, review, and update clinical design control documents including technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in moderately complex product development.
  Ensure medical and scientific factors are considered during cross-functional product development project team meetings.
  Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports.
  Evaluate collected data documentation and imaging media, draw findings, and make recommendations to complete product evaluations, product complaint review and other required interim or final reports.
• Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.

What you'll need (required):

• Bachelor's Degree in biological or Lifesciences field
• 3 years previous related experience in Class II and III medical device technologies and/or clinical studies background

What else we look for (preferred):

• Bachelor's Degree in engineering

• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with documentation management systems (e.g., Ignite)
• Excellent written and verbal communication skills and interpersonal relationship skills
• Demonstrated problem-solving and critical thinking skills
• Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
• Moderate understanding of pre-clinical testing protocols, hospital environments and sterile techniques
• Moderate knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
  

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).