Regulatory Specialist II (REMOTE, USA)

Compensation:  $90,000 to $100,000 per year. You are eligible to a Short-Term Incentive Plan with the target at 5% of your annual earnings, terms and conditions apply.

Regulatory Specialist II (REMOTE, USA)

Job Overview: 

The Regulatory Specialist is responsible for ensuring that our products and services comply with applicable regulations and standards. This role involves preparing and submitting regulatory documents, maintaining compliance with local and international regulations, and risk management.   They will participate in department and cross-functional projects by identifying regulatory operations activities for project schedules.  This individual will collaborate with cross-functional teams to support the growth of Ambry products and pharmaceutical partnerships. 

Essential Functions:

• Documentation and Submission:
  • Coordinate and support preparation of submission regulatory documentation, including pre-market submissions, product registrations, and amendments.
  • Maintain accurate and up-to-date regulatory records and files.
• Regulatory Compliance:
  • Monitor and interpret regulations related to genetic testing, including FDA, CLIA, NYS , international regulations, IVDR, UK MDR2002 and other relevant standards.
  • Ensure compliance with regulatory requirements throughout the product lifecycle and post market monitoring.
  • Maintain, review and/or update regulatory documentation.
  • Review labeling, packaging and package inserts, marketing materials.
  • Write and review SOPs, write and support multiple regulatory writing activities.
• Risk Assessment and Management:
  • Identify potential regulatory risks and develop strategies to mitigate them.
  • Conduct regulatory audits and assessments to ensure compliance and readiness for inspections.
• Cross-Functional Collaboration:
  • Work closely with R&D, clinical operations, quality assurance, IT, and marketing teams to provide regulatory guidance and support.
• Stay informed on industry trends, regulatory changes, and emerging technologies in genetic testing and IVDs.
• Other duties as assigned.

Qualifications: 

• Bachelor’s degree in life science field (i.e., molecular genetics, biology, microbiology, chemistry, engineering, medical technology, regulatory science), or equivalent experience 
• Min 3yrs of medical device and/or clinical diagnostics regulatory experience required
• Knowledge of international and federal, state, and accreditation body requirements (CAP, CLIA, NY, FDA, PMDA, EU)
• Strong analytical, written/verbal communication, interpersonal, and relationship building skills
• Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams
• Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs
• 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.
• Experience in writing technical and regulatory documentation.

Preferred:

• Master’s degree preferred
• Regulatory Affairs related Training/Certification desirable (RAC)
• Experience with:
  • Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, CTA’s applications, Investigational Device Exemption (IDE) requirements
  • Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR
  • Software validation and risk management
  • Cybersecurity in medical devices
  • Lifecycle management of medical devices/IVDs

#LI-AC1 #LI-REMOTE

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, 401k with a 4% employer match, FSA, paid sick leave and generous paid time off (PTO) program. The Company reserves the right to make changes to the 401k plan from time to time. 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 in second chance employment.  Qualified applicants with arrest or conviction history will be considered regardless of their arrest or conviction history, consistent with local laws such as Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.  You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if the Company is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. For the purpose of the above job description, “Essential Functions” are “Material Job Duties”.

Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

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. If you have a disability or special need that requires accommodation, please contact us at careers@ambrygen.com

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.

PRIVACY NOTICES

To review Ambry’s Privacy Notice, Click here:  https://www.ambrygen.com/legal/privacy-policy

To review the California privacy notice, click here: California Privacy Notice | Ambry Genetics

To review the UKG privacy notice, click here: California Privacy Notice | UKG