focus areas in translational multi-omics technologies, biomarkers identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With more than $3 billion in revenue and over 11,000 employees, Revvity serves customers across medical and biotech, diagnostic labs, academia, and governments.
It is part of the S&P 500 index and has customer in more than 190 countries. JOB SUMMARYOur team is seeking a Senior Manager Quality Assurance to join us in our efforts to serve patients and families around the world. As the Senior Manager Quality Assurance, you will join the exciting area of genomic laboratory and companion diagnostics (CDx) solutions and services. You
will serve as the strategic project regulatory leader to provide strategic and tactical support with cross-functional development and laboratory service teams. You will act as a steward for Regulatory Affairs and have the opportunity to work with a team of professionals while collaborating with external medical company leaders to revolutionize the healthcare industry.
You will work closely with our Chief Scientific Officer to establish and execute regulatory strategies, negotiate with the FDA, lead FDA pre-submission packages, and author final product submission: IDE, 510(k), De Novo, PMA, and PMA supplements. In addition, you will work with cross functional team and Revvity Global Quality
Regulatory, Clinical Affairs (QRC) department throughout the entire product lifecycle from innovation concept, development, product launch, and post commercialization within the appropriate time guidelines.
Join our team to utilize your expertise to revolutionize what's possible in healthcare, with specialized focus in translational multi-omics technologies, biomarker identification, prediction, screening, detection, and diagnosis, informatics and more. DUTIES AND RESPONSIBILITIESEstablish Quality Management System (QMS) for Omics Companion Diagnostics (CDx) / In Vitro Diagnostics (IVD) business. Understand and communicate industry standards, regulatory requirements and feedback from healthcare authorities.
Provide quality input and direction for the Omics business. Partner with Omics business leaders to develop and implement compliant regulatory and quality assurance strategies. Implement and maintain an agile QMS with a risk-based approach. Develop KPIs and report on performance. Identify opportunities for improvement. Interface with Revvity business partners to ensure best utilization of QMS and internal partnerships. Provide Design Control guidance to ensure products comply with regulatory requirements, customer expectations, and Revvity standards.
Serve as Omics primary point of contact for Quality aspects with healthcare authorities and medical customers. Partner with customers and development teams to ensure successful completion of projects. Collaborate with technical and clinical team members to develop documentation required for regulatory submissions. Manage post market surveillance including customer complaint management. Manage audits and inspections to achieve proper ISO certificates for QMS per master plan. Maintain up-to-date knowledge of CDx and IVD regulations and applicable guidance; monitor development of regulations, and communicate impact to the business.
BASIC QUALIFICATIONSBachelors degree in life sciences.12 or more years of experience in quality, regulatory or clinical studies within the medical device or medical industry. In Vitro Diagnostics experience. Experience with US FDA clinical trials and regulatory submissions (IDE, 510(k), PMA). Familiarity with operation of laboratory instruments and applicable computer software. Ability to take direction and multi-task in a demanding environment. Ability to work independently and proactively with minimal supervision. Exceptional negotiation and critical thinking skills.
Superior interpersonal, verbal, and written communication skills. PREFERRED QUALIFICATIONSCompanion Diagnostics experience. Advanced degree or equivalent work experience. Successful experience collaborating with global cross-functional teams across multiple work locations. DIRECT REPORTS There are no direct reports in this role. WORKING CONDITIONSMinor exposure to clinical and research lab environment; exposure to blood borne pathogens; must wear personal protective equipment including lab coat, gloves and completely closed footwear while in the Laboratory. Ability to travel up to 25%, both domestic and international.
BENEFITSWe provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits: Medical, Dental, and Vision Insurance OptionsLife and Disability Insurance Paid Time-Off Parental Benefits401k with Company Match Employee Stock Purchase Plan Learn more about Revvity's benefits by visiting our Why Revvity page. PDN-9a854c78-ec67-43f7-a88c-18e8d0f0cb86
