QARA Manager
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Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Job description
We are seeking an experienced and driven QA/RA Manager with a strong Design Assurance focus to join an exciting early-stage medical device company at a pivotal point in their growth journey. This is a rare opportunity to play a lead role in bringing a genuinely life-changing product to market a catheter-based device designed to improve quality of life for patients in palliative care.
Working within a passionate fast-moving start-up environment youll take ownership of design control processes drive regulatory compliance and act as a key bridge between R&D and quality as the company accelerates from Phase 2 to Phase 4 over the next 18 months. If you thrive in an environment where your work truly matters and where no two days are the same this is the role for you.
Key Responsibilities include but are not limited to the following:
Lead and maintain Design Control processes in compliance with FDA 21 CFR Part 820 ISO 13485 and EU MDR
Ensure robust implementation of design inputs outputs verification and validation activities
Oversee Design History File (DHF) completeness accuracy and audit readiness
Drive risk management activities in accordance with ISO 14971 including FMEA and hazard analysis
Ensure usability engineering and human factors requirements are fully integrated into product development
Support test methods validation and reporting for biocompatibility sterilisation packaging integrity ageing and bench testing
Partner with R&D to embed quality into product design from concept through to commercialisation
Support design changes ensuring proper impact assessment and regulatory compliance
Develop implement and maintain the Quality Management System (QMS)
Oversee CAPA deviations and non-conformance processes related to design and development
Lead internal and external audits including design-focused regulatory inspections
Provide regulatory guidance and support preparation of documentation for FDA and CE marking submissions
Mentor and provide training to QA/RA team members on design controls regulatory requirements and quality practices
Collaborate cross-functionally with R&D Clinical and Product Management teams
Job requirements
Bachelors Degree in Engineering Life Sciences or a related field
10 years experience in Quality Assurance Regulatory Affairs or Design Assurance within a medical device environment
Deep knowledge of FDA 21 CFR Part 820 ISO 13485 EU MDR and ISO 14971
Demonstrated experience managing Design History Files and leading design control processes
Firsthand experience of regulatory authority audits
Strong track record in team building stakeholder management and cross-functional collaboration
Ability to influence design decisions through data-driven insights
Familiarity with eQMS systems
Preferred Attributes
Experience hosting and leading FDA and other regulatory authority audits
Background in early-stage or start-up medical device companies
Comfortable working at pace with a high degree of autonomy
Strong attention to detail with excellent written and verbal communication skills
Motivated by meaningful work with direct patient impact
Whats on Offer
Competitive contractor day rate based on experience
The chance to make a genuine impact at a critical stage of product development
Collaborative purpose-driven team culture
A role where your expertise directly shapes patient outcomes
Immediate interviews available for suitable candidates.
Note: By applying for this position you may also be considered by Pale Blue Dot Recruitment for other or future relevant vacancies.
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