Sr. Product Development Specialist ( Cardiology/Genetic Testing)- Remote, USA
Ambry GeneticsAbout the role
Essential Functions
- Oversee the product development lifecycle, ensuring compliance with regulatory standards (e.g., CLIA, CAP, NYS, FDA)
- Work closely with clinical, regulatory, marketing, and support teams to gather insights, refine product offerings, and develop effective go-to-market strategies • Collaborate in development and validation testing processes to ensure products meet quality standards and regulatory requirements
- Bring product concepts through product development phases working in collaboration with counterparts in regulatory, Product Management & M arketing and Project Management Organization.
- Identify key requirements for products or updates that fit internal and client needs
- Formulate and establish product design in collaboration with cross-functional teams to ensure product and project success
- Present findings and project updates to core team and other stakeholder groups
- Assess and analyze competitor products
- Analyze and stay abreast of medical/scientific literature and standard of care guidelines regarding genetic testing and methodologies
- Assist with and contribute to regulatory development framework and submissions
- Review and edit scientific content in related marketing collateral
- Other duties as assigned
- Bachelor’s degree in Genetics, Biotechnology, Molecular Biology, or a related field or equivalent professional experience
- 5+ years of experience in product development or management within the genetic testing or biotechnology industry Genetic testing laboratory experience desired, proven track record of successfully launching genetic testing products from concept to market.
- Must have a strong understanding of the current state of genetic testing industry, in addition to a broad knowledge of the field of clinical genetics
- Strong understanding of product lifecycle management, regulatory requirements, and agile methodologies.
- Excellent communication and interpersonal skills, both written and oral
- Exceptional analytical and problem-solving skills
- Work very well independently, be able to collaborate and communicate with internal team members both remote and on-site
- Adaptable to a dynamic and fast-paced environment
- Master’s or PhD preferred
- Familiarity with Clinical and Laboratory Standards Institute (CLSI) standards
- Experience with FDA IVD product development plans and submissions
- Proficiency in project management tools and software
About Us:
Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster.
At Ambry, everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cutting-edge genetic testing solutions and continually sharing what we learn with the global scientific community.
At Ambry you will be learning, challenging yourself, and having fun while collaborating with teammates through the open exchange of ideas. Our outstanding benefits program includes medical, dental, vision, FSA, paid sick leave and generous paid time off (PTO) program. You can learn more about the benefits here. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.
The Company believes
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