Location: Sunnyvale, CA (Onsite)
Employment Type: Direct Hire / Full-Time
Compensation:$200,000–$275,000 annually
Yoh is seeking an experienced Director of Regulatory Affairs & Quality Assurance to join an innovative molecular diagnostics company developing a novel blood-based cancer screening technology.
This is a high-impact, hands-on leadership opportunity to drive FDA regulatory strategy, oversee premarket submissions, and build and maintain a scalable Quality Management System (QMS) as the organization advances toward FDA marketing authorization and commercialization.
The ideal candidate brings demonstrated FDA submission leadership, strong quality systems expertise, and the ability to operate both strategically and tactically within a collaborative, entrepreneurial environment.
What You'll Be Doing
Regulatory Affairs
- Develop and execute U.S. regulatory strategies for molecular diagnostic products, including FDA premarket submissions, PMAs, supplements, and Q-Submissions.
- Serve as a primary point of contact with the FDA and other regulatory authorities.
- Lead regulatory activities supporting clinical studies, including IDE requirements, IRB compliance, and informed consent.
- Author and review regulatory submission documentation, including analytical and clinical validation summaries, labeling, risk assessments, and software-related documentation.
- Monitor evolving IVD regulatory requirements and provide strategic guidance to leadership.
Quality Assurance & Compliance
- Build, maintain, and continuously improve a QMS compliant with FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971.
- Oversee design controls, document control, change management, supplier qualification, internal audits, and management reviews.
- Lead CAPA, nonconformance, complaint-handling, and quality improvement activities.
- Prepare for and lead FDA inspections, including management of Form 483 responses and corrective actions.
- Establish and oversee applicable post-market surveillance and reporting processes.
Leadership & Organizational Development
- Lead and develop the Regulatory Affairs and Quality Assurance functions, including future team expansion.
- Partner with scientific, clinical, and executive leadership to support product development and regulatory milestones.
- Establish quality and regulatory priorities, processes, and performance metrics.
- Promote a culture of accountability, quality, and regulatory compliance throughout the organization.
- Communicate regulatory strategies, risks, and progress to senior leadership.
What You Need to Bring to the Table
Required Qualifications
- Bachelor's degree in life sciences, engineering, or a related field.
- 12+ years of progressive Regulatory Affairs and/or Quality Assurance experience within the IVD or medical device industry.
- 5+ years of people leadership experience.
- Demonstrated hands-on leadership of at least one successful FDA premarket submission (PMA, De Novo, or 510(k)); PMA experience strongly preferred.
- Experience building, implementing, or remediating quality management systems compliant with 21 CFR Part 820, ISO 13485, and ISO 14971.
- Direct experience hosting FDA inspections and managing Form 483 responses.
- Working knowledge of FDA regulations, including 21 CFR Parts 803, 806, 809, and 812.
- Strong understanding of design controls and regulatory compliance for IVDs or medical devices.
- Excellent communication skills, including direct interactions with FDA reviewers and executive leadership.
- Ability to work onsite in Sunnyvale, CA.
Preferred Qualifications
- Advanced degree (MS, PhD, PharmD) in a relevant discipline.
- Regulatory or quality leadership experience in molecular diagnostics, oncology, liquid biopsy, NGS, or cancer screening.
- Experience with FDA Breakthrough Devices Program and Q-Submissions.
- Familiarity with software/algorithm validation and medical device cybersecurity requirements.
- RAC, ASQ CQA, or CMQ/OE certification.
- Experience in an early-stage, venture-backed, or rapidly growing life sciences organization.
What's In It for You?
- Opportunity to lead regulatory and quality strategy for an innovative cancer-screening technology.
- Direct impact on critical FDA milestones and future commercialization.
- High-visibility leadership role working closely with scientific and executive teams.
- Opportunity to build and shape the RA/QA function as the organization grows.
- Entrepreneurial environment with meaningful ownership and long-term growth potential.
Compensation
The anticipated base salary range is $200,000–$275,000 annually, depending on qualifications, experience, and relevant expertise.
Additional compensation and benefits may be available and will be discussed during the recruitment process.
Apply Now
If you have successfully led FDA premarket submissions, built or improved regulated quality systems, and are interested in a hands-on leadership opportunity within molecular diagnostics, we encourage you to apply.
Yoh is 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, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Qualified applicants with arrest or conviction records will be considered in accordance with applicable law.
#IND-SPG
Estimated Min Rate: $200000.00
Estimated Max Rate: $275000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is 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, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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