Our team

AlvaMed is a team of industry experts experienced in bringing new medical devices to market and keeping marketed devices in compliance. Let us provide your medical device registration and approval support, QMS compliance, regulatory affairs, CRO and clinical affairs outsourcing. Talk to us about having our industry veterans becoming your company’s regulatory, quality and clinical affairs leads without the costly overhead.

MARK COX

President and Founder Mark Cox has over 25 years of experience helping clients throughout North America and Europe value technologies, and develop and introduce new medical products. His expertise includes due diligence management, technology transfer and licensing, IP valuation and strategy, and product cost analysis.

ERIC BANNON

Eric Bannon is Senior Vice President of Regulatory and Clinical Affairs at AlvaMed. Eric has 40 years of experience providing regulatory and clinical support for medical device companies. His expertise focuses on implementing creative regulatory and clinical strategies from development through commercialization with experience in multiple therapeutic areas both in the US and abroad.

JON SALTONSTALL

Jon Saltonstall is Senior Vice President of Regulatory and Quality Compliance at AlvaMed. Jon has more than 25 years of hands-on experience developing sterile, single use catheters, disposables and implants. Jon has held quality assurance leadership roles in several startup companies from pre-clinical to early stage commercial. He has expertise in quality system design and implementation as well as design controls, risk management and manufacturing transfer.

DIANA GRENIER

Diana Grenier is Vice President of Quality Compliance at AlvaMed. Diana has more than 30 years of experience in project and quality engineering, primarily in the design, qualification and manufacture of medical devices. Her expertise is in management of QA and QMS projects, ensuring compliance to Quality System Regulations including ISO 13485, Medical Device Regulation and 21 CFR Part 820.

MARC QUARTULLI

Marc Quartulli is the Vice President, Clinical Affairs of AlvaMed. Marc has over 25 years of experience in clinical research on pre- and post-market studies both domestically and internationally. Prior to joining AlvaMed Marc spent over 11 years at Conformis, Inc.

BRIAN LUDOVICO

Brian Ludovico, Director of Quality Affairs, has over 25 years of experience in quality management systems and global regulatory requirements of medical and in vitro diagnostic devices. Brian spent 21 years at the European Notified Body TÜV Rheinland.

KEIRA JESSOP

Keira Jessop is a Director of Regulatory Affairs at AlvaMed with 20 years of experience in the medical device industry with her principal experience in building the technical documentation to support regulatory submissions.

KERRY BECKETT

Kerry Beckett is Clinical and Regulatory Affairs Manager at AlvaMed.  Kerry has more than 15 years of experience managing and supporting clinical research, regulatory affairs and quality assurance projects. Kerry held senior level specialist roles in clinical, regulatory and quality affairs prior to joining AlvaMed.

CHELSAE O’HALLORAN

Chelsae O’Halloran has over 10 years of experience in Quality Systems, Quality Engineering and Design Assurance. She has worked in various environments, including pre-clinical and early-stage commercial startups, a fortune 500 company, and a mid-size contract R&D and manufacturing company.

RUPALI KUMAR

Rupali Kumar is a Regulatory Affairs Consultant at AlvaMed with experience in the preparation and submission of medical device regulatory submissions. Rupali is adept in providing valuable regulatory and clinical support to clients.

MELISSA HOOPER

Melissa Hooper has 10 years of experience managing and supporting regulatory and quality assurance projects. Her primary expertise is developing and maintaining quality management systems that ensure compliance to global and regional regulations. She is also practiced in supporting 510(k) regulatory submissions.

AMELIA MOTTET

Amelia (Mali) Mottet has experience in Quality and Design Assurance. Mali has 5 years of experience in Design Assurance. She has worked for a mid-size contract R&D and manufacturing company and supported programs for Class I and II medical devices for start-up, mid-size, and large medical device companies. Additionally, Mali has supported large company QMS (Quality Management System) harmonization programs.

MARCI KELLEY

Marci Kelley has over ten years of experience working in Quality Assurance. She has held QA Document Control positions in large and small biotech and pharmaceutical companies.