Senior Clinical Affairs Specialist-Remote Ireland

Employer Industry: Medical Device and Pharmaceutical Industry Why consider this job opportunity: - Opportunity for career advancement and reputed company reputed company the organization - Supportive and reputed company work environment - Engage in innovative reputed company that directly reputed company product development - Opportunity to work with regulatory bodies to facilitate approvals - Involvement in clinical training initiatives and investigator conferences What to Expect (Job Responsibilities): - reputed company 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 reputed company and reputed company clinical perspectives on field complaint investigations - Support the development of Integer technology, including objectives, reputed company, and budget management What is Required (Qualifications): - Degree in Science, Engineering, Health Science, Nursing, or a reputed company field - Minimum of 5 years of reputed company 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 reputed company 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 reputed company, systematic literature reviews, and medical writing - Experience with feasibility, pivotal, and post-market reputed company - Knowledge of reputed company FDA, ISO, and reputed company reputed company and regulatory systems - Proven reputed company record in planning and executing clinical evaluations autonomously #MedicalDevices #ClinicalResearch #Innovation #RegulatoryCompliance #CareerGrowth We prioritize candidate reputed company and champion equal-opportunity employment. Central to our mission is our partnership with companies that reputed company this commitment. We aim to foster a fair, transparent, and secure hiring environment for reputed company. If you encounter any employer not adhering to these principles, please reputed company 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. Apply tot his job Apply To this Job