Director, Software & IT Compliance
Adaptive BiotechnologiesAdaptive Biotechnologies is harnessing the immune system to unleash its power as a natural diagnostic and therapeutic tool to propel a paradigm shift in medicine.
We are powering the age of immune medicine–you can too. At Adaptive, our goal is to harness the power of the adaptive immune system to make a difference in the lives of people living with many different diseases.
As an Adapter, you will be surrounded by driven colleagues who think boldly and innovate fearlessly. You will experience meaningful challenges in your work and be fueled by the knowledge that you’re making a difference in patient’s lives.
You belong here – come discover your story at Adaptive.
Leads the Software Engineering and IT Compliance team to maintain product software quality and IT service quality, envisions and implements risk-based solutions that support technology product/service development and delivery in an Agile environment. Manages software classification and regulatory support for submissions in the US and rest of world and is the audit representative for the Software Engineering team. Manages IT Service Management (ITSM) process and leads the support of all IT-related audits.
Key Responsibilities and Essential Functions
- Expert knowledge of all agile principles, software, information security, privacy, medical devices regulations (ISO 13485, ISO 14971, IEC 62304, IVDD, MDR), and lab-related (CLIA, CAP, CLEP, GxP) regulations and standards.
- Establish and manage streamlined ITSM process based on ITIL v4 and ISO 27001, lead IT service quality review and support all IT-related audits such as SOX, SOC 2, and pharma partner audits.
- Leads strategies to implement compliant and efficient policies and procedures that govern IVD-related product software development and delivery.
- A risk and system-based solution provider that ensures software compliance is integrated throughout the organization and meets all stakeholder, quality management system regulations, standards, guidance and contractual obligations.
- Manages all IVD-related product software data that supports submissions and includes the implementation and maintenance of software development plans, product software classifications and risk management activities.
- Maintains a team charter and achieves metrics that are harmonized with corporate goals and priorities.
- Audit representative for the Software Engineering team and prioritizes and resolves internal/external audit findings.
- Performs Software Periodic Reviews, contributes to Management Reviews and advises management of any product or process related issues and makes recommendations for improvements.
- Stays current with various quality compliance and regulatory topics.
- Identifies potential issues and minimizes regulatory risks through creative problem solving.
- Promotes a positive quality and regulatory culture within the organization.
- Strong interpersonal and verbal/written communication skills.
Position Requirements (Education, Experience, Other)
- 15+ years’ experience in the medical device industry and advance competency with software medical devices or IT services in regulated environment.
- Bachelor’s degree in a relevant scientific discipline.
- Experienced with US and EU regulations, standards and guidance applicable for IVD, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA/CAP laboratories are highly desirable.
- Certification in a Biomedical Regulatory Affairs program highly desirable.
- Certified Auditor for ISO 13485, and Certified Biomedical Auditor, Certified Medical Device Auditor or Certified Auditor Certification highly desirable.
This role may require flexibility in working schedule, including more than standard hours when necessary and occasional evenings or weekends.
This role will require significant time working at a computer laptop or workstation.
Salary Range: 179,800 - $269,600
Other compensation elements include:
- equity grant
- bonus eligible
Interested in this position, but don’t meet all the requirements? Adaptive is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!
Adaptive's benefits at-a-glance.
Adaptive Biotechnologies is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Opportunity Employer/Veterans/Disabled
Interview accommodations may be requested during initial interview scheduling communications.
NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.
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