Integer
Senior Clinical Affairs Specialist-Remote Ireland
Integer, Jonesboro, Texas, United States, 76538
Employer Industry: Medical Device and Pharmaceutical Industry
Why consider this job opportunity:
Opportunity for career advancement and growth within the organization
Supportive and collaborative work environment
Engage in innovative projects that directly impact product development
Opportunity to work with regulatory bodies to facilitate approvals
Involvement in clinical training initiatives and investigator conferences
Responsibilities
Develop global clinical strategies for product submissions and support post-submission activities
Represent the Clinical Affairs function on product development teams and ensure compliance with regulatory requirements
Generate interim and final reports as the first author
Monitor clinical trials and provide clinical perspectives on field complaint investigations
Support the development of Integer technology, including objectives, strategy, and budget management
Qualifications
Degree in Science, Engineering, Health Science, Nursing, or a related field
Minimum of 5 years of professional experience in the medical device or pharmaceutical industry; 10 years if a degree is not a prerequisite
Experience with US and international medical device regulatory submissions and approvals
In-depth knowledge of medical device regulations and quality system requirements
Proven ability to work independently and collaboratively across the organization
Preferred Qualifications
Experience with implantable devices or high-risk device types
Familiarity with research methods, systematic literature reviews, and medical writing
Experience with feasibility, pivotal, and post-market clinical trials
Knowledge of current FDA, ISO, and related quality and regulatory systems
Proven track record in planning and executing clinical evaluations autonomously
#MedicalDevices #ClinicalResearch #Innovation #RegulatoryCompliance #CareerGrowth
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Why consider this job opportunity:
Opportunity for career advancement and growth within the organization
Supportive and collaborative work environment
Engage in innovative projects that directly impact product development
Opportunity to work with regulatory bodies to facilitate approvals
Involvement in clinical training initiatives and investigator conferences
Responsibilities
Develop global clinical strategies for product submissions and support post-submission activities
Represent the Clinical Affairs function on product development teams and ensure compliance with regulatory requirements
Generate interim and final reports as the first author
Monitor clinical trials and provide clinical perspectives on field complaint investigations
Support the development of Integer technology, including objectives, strategy, and budget management
Qualifications
Degree in Science, Engineering, Health Science, Nursing, or a related field
Minimum of 5 years of professional experience in the medical device or pharmaceutical industry; 10 years if a degree is not a prerequisite
Experience with US and international medical device regulatory submissions and approvals
In-depth knowledge of medical device regulations and quality system requirements
Proven ability to work independently and collaboratively across the organization
Preferred Qualifications
Experience with implantable devices or high-risk device types
Familiarity with research methods, systematic literature reviews, and medical writing
Experience with feasibility, pivotal, and post-market clinical trials
Knowledge of current FDA, ISO, and related quality and regulatory systems
Proven track record in planning and executing clinical evaluations autonomously
#MedicalDevices #ClinicalResearch #Innovation #RegulatoryCompliance #CareerGrowth
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
#J-18808-Ljbffr