Director/ Sr. Director

Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based diagnostics. Our core RNAscope® technology is the world’s first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope® is an ideal platform for developing the next generation of tissue-based companion diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical medicine to fulfill the promise of personalized medicine.



The Senior Director of Quality Assurance and Regulatory Affairs will be responsible for developing Quality/Regulatory policies and strategies with the ACD Management Team and implementing them within the department and company. Ensure the Company’s quality system is in compliance with all relevant regulations and standards set forth by regulatory, quality and/or accrediting agencies.  The Senior Director of QA/RA is also responsible for the development of regulatory submissions (whether domestic and international), as well as dealing with any compliance-related matter. This position reports directly to the Vice President of ACD and is based in Neward, California.

2018 February 14

Education Experience

  • B.S. degree in a relevant field of science or related field; advanced degree and Regulatory Affairs Certification is preferred.

Preferred Qualifications

  • Minimum 10 years experience in regulatory, development, clinical affairs, quality, or program management within the research reagents, diagnostic, or life sciences companies.
  • Experience with CE Mark/IVDD, 510(k) and PMA and worldwide regulatory submissions and working under a highly regulated environment is required; experience with PMA submissions is highly desirable.
  • Knowledge of global regulatory and Quality Systems requirements for IVDs and research reagents, instruments and software is required.
  • Demonstrated work experience in all phases of device/ diagnostic/ biologic registration and approval, from pre- to post-launch.
  • Professional and scientific interface established within both professional societies and particularly with the FDA/other governmental entities.
  • Prior experience within other functional areas is desirable; prior experience in developing/leading quality systems is required.
  • Strong team player.
  • Ability to thrive and flourish in an entrepreneurial early stage company environment that requires “hands-on” implementation, optimal use of limited resources and an ability to work closely with others in a small team setting.
  • Demonstrated ability to participate in and lead cross-functional teams and to achieve results through cooperation with other departments.
  • Excellent interpersonal, presentation, written and verbal communication skills.
  • Ability to work with the management team and regulatory authorities to meet corporate goals and initiatives while dealing within a somewhat “murky” and rapidly changing regulatory environment.
  • Strong time management and organizational skills coupled with a sense of urgency and strong work ethic.
  • Must be a highly motivated self starter and show initiative; however, also must be attentive to detail and strongly adhere to quality and regulatory mandates.

Duties and Responsibilities

  • Direct regulatory activities and set regulatory strategy and policy for regulated products.
  •  Lead and ensure timely preparation of organized and scientifically valid product submissions.
  •  Identify areas of potential regulatory compliance jeopardy at plant, research and development, and division levels and assists in the development of programs to relieve potential risk.
  • Interact with Regulatory Agencies to ensure that quality systems are adequate and facilities are compliant.
  • Oversee the development and maintenance of Quality Systems both in-house and oversight at contract manufacturers and raw materials suppliers.
  • Provide leadership for division, coordinating corporate programs and divisional regulatory compliance initiatives.
  • Guide all parts of the organization on Quality Systems and regulatory compliance in areas such as design control, manufacturing, validation, and analytical methods.
  • Lead and develop regulatory scientific staff, provides leadership for specific projects and acts as liaison between divisions, and other companies.
  • Interacts directly with regulatory authorities and represents ACD in dealing with regulatory agencies for product submissions.
  • Monitor the manufacturing, development and Quality processes to ensure conformance and compliance with all FDA and applicable international regulations at corporate and monitor consistency within the company.
Contact Us

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Advanced Cell Diagnostics

Our new headquarters office starting May 2016:

7707 Gateway Blvd.  
Newark, CA 94560
Toll Free: 1 (877) 576-3636
Phone: (510) 576-8800
Fax: (510) 576-8798


Advanced Cell Diagnostics , S.r.l.

Via Calabria15
20090 Segrate (Milano) - Italy

Phone: +39.02.95360323
Fax: +39.02.95360992
For European orders:

Advanced Cell Diagnostics China

Building 15, No. 26 Xihuan South Road
Beijing Economic-Technological Development Area
Beijing, China, Zip code: 100176

For general information: Leon Li

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