iO Associates · 9 hours ago
Regulatory and Quality Director
United States
Full-time
Remote
Director/Executive
10+ years expiO Associates is a leading organisation committed to innovation and excellence in healthcare, seeking a strategic and dynamic Regulatory and Quality Director to lead compliance and quality initiatives. The successful candidate will influence global regulatory strategies and uphold the highest standards of quality across diverse markets.
ConsultingRecruitingStaffing Agency
Hiring Manager
Elliott Evans
Responsibilities
Develop and execute comprehensive regulatory plans for both new and existing products, ensuring timely approvals across international markets
Oversee all submissions to regulatory bodies, managing communication and ensuring compliance with evolving standards
Lead the design and implementation of robust quality management systems aligned with international standards, including ISO 13485, MDSAP, and FDA QSR
Manage internal and external quality audits, driving corrective actions and continuous improvement
Provide leadership to the Regulatory and Quality teams, fostering a culture of excellence and professional development
Collaborate seamlessly with cross-functional teams to embed compliance and quality into all operational processes
Cultivate strong relationships with external stakeholders, including regulatory agencies, partners, and consultants, ensuring alignment on compliance matters
Identify potential regulatory risks and develop strategic mitigation plans
Design and deliver training programmes to elevate understanding of compliance requirements organisation-wide
Qualification
Required
A minimum of 10 years' experience in regulatory affairs and quality assurance within the medical device or pharmaceutical sectors
Proven success in managing regulatory submissions and securing approvals in multiple jurisdictions
Deep knowledge of global regulatory frameworks and quality standards such as ISO 13485, MDSAP, FDA QSR, and EU IVDR
Demonstrable leadership and team management capabilities, with an ability to inspire and develop staff
Broad understanding of manufacturing processes in a medical device environment
Strong organisational skills, with the ability to juggle multiple priorities and meet deadlines
Preferred
RAC certification or equivalent qualification would be advantageous
Experience working with electronic quality management systems (eQMS)
Past involvement in strategic planning and regulatory risk management
Excellent interpersonal and communication skills, capable of training and presenting to diverse audiences
Company
iO Associates
iO is an industry leading IT search firm, with specialist disciplines including FinTech, development, analytics, IT security and more.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Neil Willis-Stovold
Founder & CEO
Mark Lloyd
Director
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