Michael Edwards
Senior Director, Regulatory Affairs (MedTech) at Premier Consulting | Weyhill, England, United Kingdom
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Michael Edwards serves as the Senior Director of Regulatory Affairs at Premier Consulting, where he leverages over 25 years of extensive experience in the medical devices and pharmaceutical sectors to drive strategic initiatives and operational excellence. In his current role, Michael is instrumental in navigating the complex regulatory landscape that emerging biotech, specialty pharma, and MedTech companies face. His deep understanding of regulatory compliance, coupled with his MBA, allows him to formulate and implement robust strategies that align with both business objectives and regulatory requirements.
At Premier Consulting, a vital arm of Premier Research, Michael leads key projects that focus on product development and lifecycle management, ensuring that clients not only meet regulatory standards but also achieve market readiness efficiently. His expertise in Design Control and Quality Control is critical in guiding teams through the intricacies of ISO 14971 and other relevant standards, thereby enhancing product safety and efficacy. Michael’s customer-focused approach and strong business acumen enable him to build lasting relationships with clients, helping them navigate the challenges of international business development and regulatory submissions.
Michael's commitment to excellence is evident in his ability to make informed decisions that balance regulatory demands with commercial viability. His leadership in developing processes and procedures has significantly improved operational workflows, ultimately contributing to the successful launch of innovative medical technologies. As a thought leader in regulatory affairs, Michael Edwards continues to shape the future of MedTech by empowering companies to bring their groundbreaking products to market while ensuring compliance and quality at every stage of development.
Senior Director, Regulatory Affairs (MedTech) at Premier Consulting in April 2023 to Present
Director of Regulatory Affairs (MedTech) at Medpace in September 2018 to December 2022
Interim Regulatory Affairs Consultant at Boston Scientific in April 2018 to September 2018
Quality Assurance & Regulatory Affairs Director at Bracco in October 2015 to April 2018
Regulatory and Technical Director at Flexicare (Group) Limited in June 2014 to September 2015
Management Consultant & Independent Medical Devices Professional at Management Consultancy Services in February 2014 to June 2014
Director of Operations & Compliance at Philips Remote Diagnostic Technologies in July 2013 to February 2014
Director of Regulatory Affairs at Mölnlycke Health Care in December 2010 to July 2013
Regulatory, Quality Systems & Design Manager at Kimal in November 2004 to November 2010
Registration Manager: Regulatory Affairs at Merial in May 2004 to November 2004
Regulatory Affairs, Quality Systems & Design Support Manager at Oxford Instruments Healthcare in November 2000 to April 2004
International Regulatory Affairs & Quality Assurance Manager at Kinetic Concepts Inc in December 1996 to November 2000
Quality Assurance Manager at Spembly Medical Limited in January 1993 to November 1996
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Medical Device Directive
Medical Device Regulation (MDR)
Medical Devices
Quality System
Regulatory Affairs
ISO 13485
Quality Assurance
Product Development
Strategy
FDA
Business Development
Quality Management
Product Launch
Design Control
Quality Auditing
CAPA
Regulatory Submissions
Project Management
Change Management
Pharmaceutical Industry
GMP
Market Development
Quality Control
Strategic Planning
Risk Management
ISO
Continuous Improvement
Manufacturing
R&D
Commercialization
Healthcare
International Business Development
V&V
Change Control
Performance Driven
Product Lifecycle Management
Cross-functional Team Leadership
Management
Leadership
Strategic Leadership
Decision Making
ISO 14971
CE marking
Regulatory Strategy Development
Business Acumen
Adverse Event Reporting
Integrity
Customer Focus
Enables Change
Clinical Investigations
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Discover more about Premier ConsultingWhat is Michael Edwards email address?
Email Michael Edwards at [email protected]. This email is the most updated Michael Edwards email found in 2026.
How to contact Michael Edwards?
To contact Michael Edwards send an email to [email protected]. (updated on November 04, 2024)
What company does Michael Edwards work for?
Michael Edwards works for Premier Consulting
What is Michael Edwards's role at Premier Consulting?
Michael Edwards is Senior Director, Regulatory Affairs (MedTech)
What is Michael Edwards's Phone Number?
Michael Edwards's phone +44 ** **** *255
What industry does Michael Edwards work in?
Michael Edwards works in the Pharmaceutical Manufacturing industry.
Michael Edwards Email Addresses
Michael Edwards Phone Numbers
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