This job has expired
This position was posted on July 9, 2026 and is likely no longer accepting applications. We've kept it here for historical reference. Check out the similar jobs below!
Job Overview
Location
Remote - Ireland
Job Type
Full-time
Category
Operations
Date Posted
July 9, 2026
Full Job Description
đź“‹ Description
- • Develop and implement clinical strategies to support clinical evidence requirements for product submissions.
- • Develop and work within specific processes to support any required post-submission activities (e.g., Post Market Clinical Follow Up data generation and evaluation).
- • Represent the Clinical Affairs function on product development teams.
- • Support compliance with all relevant regulatory, clinical, and standard requirements that apply.
- • Advance clinical data integrity in support of the quality and regulatory functional group needs.
- • Use software to appraise, analyze, and evaluate clinical and state-of-the-art data to generate appropriate clinical evidence to support Integer Technologies and Projects.
- • Manage any updates to appraisal forms, workflows, reporting outputs.
- • Be first author and responsible for the generation of interim and final reports.
- • Support Integer initiatives with market-specific clinical training.
- • Convene and direct investigator conferences to review findings and advise on direction.
- • Select, interface with, and assure training of investigators/physicians, centre staff, and Integer Clinical Affairs staff.
- • Provide a clinical perspective and approval on field complaint investigations, recall decisions, or other instances where a clinical opinion is needed.
- • Ensure adequate monitoring is conducted on all clinical trials.
- • Work directly with regulatory bodies for the purpose of facilitating regulatory approvals and queries.
- • Support the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof of concept through post-commercial regulatory.
🎯 Requirements
- • A degree from higher education (Science, Engineering, Health Science, Nursing, or related field).
- • 5 years of documented professional experience in the medical device industry or pharmaceutical industry, including US and international medical device regulatory submissions/approvals.
- • Experience with implantable devices and/or other high-risk device types.
- • Suitably qualified as per MEDDEV 2.7.1 (rev 4), section 6.4 with experience of research methods, information management, systematic literature reviews, and medical writing.
- • In-depth knowledge with various medical device regulations such as the Medical Device Regulation (2017/745), 21 CFR Part 812, and standards/guidance documents such as MEDDEV 2.7.1 (rev 4), MDCG 2020-5, MDCG 2020-6, ICH Guidelines, and their application.
- • Knowledge and experience with current US-FDA, ISO, and other related quality and regulatory system requirements and how they interact with the business.
- • Experience working with the medical community, including physicians.
- • Clinical experience with feasibility, pivotal, and post-market clinical trials.
- • Strong leadership skills with demonstrated ability to drive positive results and deliver projects and their deliverables on time and within budget.
🏖️ Benefits
- • Competitive salary.
- • Comprehensive benefits package.
- • Opportunities for professional growth and development.
- • Collaborative and dynamic work environment.
- • Recognition and rewards for outstanding performance.
Skills & Technologies
See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.
About Integer Holdings Corporation
Integer Holdings Corporation is a medical device outsource manufacturer specializing in components for cardiac, neuromodulation, vascular and portable medical markets. It designs and produces batteries, capacitors, catheters, leads, molded components, and assemblies used in implantable and external devices. Headquartered in Plano, Texas, the company operates FDA-registered facilities across North America, Europe and Asia, serving original equipment manufacturers under stringent quality and regulatory standards. Its products support critical therapies including rhythm management, pain management and minimally invasive surgery, enabling OEMs to accelerate innovation while reducing manufacturing risk and cost.
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
Onhires Inc.
2 months ago
Onhires Inc.
2 months ago
Hangar Aviation Technologies, Inc.
3 months ago
Bjak Sdn. Bhd.
1 month ago