Senior Clinical Affairs Specialist-Remote Ireland

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 We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. 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. Apply tot his job