Remote Director

Ambry Genetics Corporation Remote
remote director regulatory genetics medical software remote cap registrations team management materials director
Ambry Genetics Corporation is now hiring Remote Director in Aliso Viejo, CA 92656. View job listing details and apply now.



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.



  • Full Time (40 hours per week)

  • Top-Tier benefits starting first of every months

  • 15 Paid Days Off

  • 12 Paid Holidays

  • Short Term Incentive Plans accelerated by YOUR performance

  • 401(k) with Company Match


*This role is 100% remote and can work out of any state in the US*


I. Job Overview:



The Regulatory Affairs Associate Director is an individual contributor that leads, plans, coordinates, conducts, and reports on in vitro diagnostics and medical device projects and programs both. Manages regulatory agency authorizations, approvals, registrations, and licensure documentation for submissions both in the US and internationally. Executes department and cross-functional projects; identifies regulatory operations activities for project schedules; serves as a core team member and core team leader; and recommends appropriate actions on regulatory and compliance issues. Provides regulatory advice, analysis and impact assessments on legislation, industry guidance, and other initiatives. Performs a wide range of analysis and regulatory intelligence discovery to support the company’s view of new next generation sequencing and software as a medical device program development.


Demonstrates knowledge of regulations, standards, and licensure requirements, such as, clinical diagnostic laboratory standards: CAP and state licensures, including NY; Federal regulations CLIA and QMS; and Industry standards: ISO 13485 Medical Device QMS; ISO 14971 Risk Management Program; IEC 62304 Software Development Lifecycle; FDA/PMDA Software as a Medical Device.



II. Duties and Responsibilities:



1. Direct and manage regulatory operations and regulatory intelligence functions for Ambry products, and strategic business partners.
2. Provide domestic and international regulation, standards and guidance interpretation and application for Ambry products, services, processes, and business strategy planning of new LDT, IVD and Companion Diagnostics regulatory strategies and tactical plans
3. Participate as an active team member on new product development teams to provide regulatory guidance and communicate with all stakeholders and senior leadership of current regulatory statuses, potential or identified risks, and mitigation solutions.
4. Lead, coordinate and prepare business interactions with customers and regulatory authorities as well as regulatory submission collation (software, reagents, assay, IT systems) and product modifications with minimum supervision, including EU/IVDR Technical Documentation, classification requests, FDA/PMDA pre-submissions, FDA 510(k) premarket notifications, and other critical registrations worldwide.
5. Direct and provide regulatory oversight and approval of all external facing materials to ensure content is source verified and incorporates all appropriate regulatory elements, content, claims and disclaimers (i.e., promotional materials).
6. Manage regulatory consultants assigned to carry out product submission and registration activities.
7. Conduct oversight on regulatory pathway, performance claims, data requests, product modifications, labeling, and advertising and promotional materials in the context of submissions, registrations, and product modifications.
8. Support document control and records maintenance per corporate policy and record retention policy.
9. Highly motivated, energetic, and enthusiastic self-starter and leadership mentality
10. Travel up to 15% to meet growing business needs
11. Flexible hybrid office verse remote work environment
12. Responsible for working outside of normal working hours due to international clients and partners



III. EDUCATION and Knowledge:



  • Bachelor’s degree in life science field (i.e., molecular genetics, biology, microbiology, chemistry, engineering, medical technology, regulatory science), and a master’s degree preferred

  • Regulatory Affairs related Training/Certification desirable (RAC)

  • Knowledge of international and federal, state, and accreditation body requirements (CAP, CLIA, FDA, PMDA, EU)





IV. TECHNICAL COMPETENCIES (Skill, Abilities and Capabilities):




  • Proficient with MS office programs (Word, Excel, PowerPoint, Projects, Visio and Outlook)

  • Strong analytical, written/verbal communication, interpersonal, and relationship building skills

  • Exercise independent judgment and discretion within a broadly defined range of policies and practices, which includes analytical problem-solving and decision-making

  • Demonstrate organizational, planning, and program management skills, including action oriented, focused urgency and driving results.

  • Effective ability to formulate and drive global change management and continuous improvement across the organization




V. EXPERIENCE:



  • Minimum of 10 years of medical device and/or clinical diagnostics regulatory experience required

  • 3 years of managerial experience preferred



About Us


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, 401k, FSA, and generous paid time off (PTO) program. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.


Ambry Genetics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, sex, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.


Ambry does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Ambry. Such resumes will be deemed the sole property of Ambry and will be processed accordingly.




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