At Adaptive Life Science, we understand that ISO 13485 compliance isn't just a regulatory requirement, it's the foundation of medical device excellence. Our specialised recruitment team connects medical device companies with seasoned ISO 13485 professionals who possess the technical expertise, regulatory acumen, and leadership capabilities to drive quality management systems forward.
The medical device industry operates in an increasingly complex regulatory landscape where quality management system failures can result in product recalls, regulatory sanctions, and compromised patient safety. Organizations need leaders who can navigate FDA requirements, EU MDR compliance, and international harmonization standards while maintaining operational efficiency and innovation momentum.
Our deep industry knowledge allows us to identify candidates who understand the nuances of design controls, risk management (ISO 14971), clinical evaluation requirements, and post-market surveillance obligations that define successful ISO 13485 implementation.
Our ISO 13485 Leadership Recruitment Portfolio
Quality Assurance & Regulatory Leadership
ISO 13485 Lead Auditor/Manager - Strategic oversight of quality management systems, internal audit programs, and regulatory compliance initiatives
Quality Assurance Director - Enterprise-wide quality strategy development and cross-functional quality culture leadership
Regulatory Affairs Director - Global regulatory strategy, submission management, and compliance oversight across multiple jurisdictions
Quality Systems & Operations Management
Quality Systems Manager - Day-to-day QMS operations, document control, CAPA management, and process improvement initiatives
Quality Control Manager - Laboratory operations, testing protocols, validation activities, and statistical quality control
Manufacturing Quality Manager - Production quality oversight, supplier quality management, and manufacturing compliance
Quality Systems & Operations Management
Risk Management Director - ISO 14971 implementation, design risk analysis, and post-market risk assessment
Clinical Quality Assurance Manager - Clinical trial quality oversight, GCP compliance, and clinical data integrity
Design Quality Manager - Design control implementation, design history file management, and design transfer oversight
We evaluate candidates beyond their resume credentials, assessing their practical experience with FDA 21 CFR Part 820, ISO 13485:2016 requirements, and emerging regulatory trends such as EU MDR and IVDR implementation. Our assessment process identifies professionals who can balance compliance rigour with business pragmatism.
Regulatory Intelligence Network
Our recruitment team maintains active relationships with regulatory professionals across Class I, II, and III medical device companies, from innovative startups to established multinational corporations. This network provides us with insights into compensation trends, skill shortages, and emerging leadership opportunities.
Technical Depth Assessment
We understand the technical nuances that separate competent quality professionals from exceptional ones. Our evaluation process examines candidates' experience with statistical process control, validation methodologies, corrective and preventive action (CAPA) systems, and management review processes.
The Adaptive Life Science Advantage
Proven Track Record
With 3+ years minimum experience requirements, we focus exclusively on professionals who have demonstrated measurable impact in previous roles. Our candidates have led successful regulatory inspections, implemented company-wide quality initiatives, and navigated complex product launch scenarios.
Market Intelligence
Our team provides clients with comprehensive market analysis, including compensation benchmarking, skills availability assessment, and competitive landscape insights that inform strategic hiring decisions.
Long-Term Partnership Approach
We don't just fill positions, we build lasting relationships with both clients and candidates, ensuring successful long-term placements that drive organisational growth and regulatory excellence.
Whether you're seeking an ISO 13485 Lead Auditor to enhance your internal audit capabilities, a Quality Systems Manager to optimize your QMS operations, or a Regulatory Affairs Director to navigate global market access challenges, Adaptive Life Science has the industry expertise and candidate network to deliver exceptional results.
Contact our specialised medical device recruitment team to discuss your ISO 13485 leadership requirements and discover how our deep industry knowledge can accelerate your quality management objectives.
Adaptive Life Science - Connecting Medical Device Excellence Through Expert Recruitment
