Integer
Senior Clinical Affairs Specialist-Remote Ireland
This job is now closed
Job Description
- Req#: R33023
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
What to Expect (Job 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
What is Required (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
How to Stand Out (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
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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.About the company
Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing.
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