Careers

Immunexpress is a privately held company developing molecular diagnostic tools to aid clinicians in improving outcomes for suspected sepsis patients. Sepsis affects more than 1.6 million patients in the US every year and is the most expensive complication contributing to patient costs in US hospitals, totaling over $20 billion each year. Sepsis is difficult to diagnose, and there is an overwhelming clinical need for better diagnostic tools.

Immunexpress’s dynamic and innovative environment offers our employees the opportunity to advance and commercialize diagnostic tools to aid in differentiating infection from non-infectious causes of systemic inflammation, as well as early identification of the type of infection, in suspected sepsis patients.

Note: Immunexpress provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, we comply with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

We are expanding our operations and welcome dedicated and talented applicants to apply to join our growing team.

Please send resumes to [email protected]; include a cover letter that highlights your qualifications and matches our requirements. Immunexpress offers competitive salaries and an excellent benefits package to its employees.

Regulatory Affairs Specialist
Seattle, WA, USA

 

TITLE

Regulatory Affairs Specialist

COMPENSATION

The successful candidate will receive a competitive compensation package.

REPORTING RELATIONSHIP

The successful candidate will report to the Director for Commercialization Programs for Immunexpress, Inc.

POSITION SUMMARY

The Regulatory Affairs Specialist will be responsible for product regulatory compliance activities including regulatory submissions, and review and creation of product labeling and design documentation to ensure compliance with US and European regulatory requirements. This individual will work with Product Development, Quality Assurance, Clinical Trials Management, and Bioinformatics to ensure the highest level of compliance with regulations.

QUALIFICATIONS & TRAINING

  • BS, MS or PhD in a related Life Sciences discipline and a minimum of 3-5 years of directly related experience within the biopharma industry – molecular diagnostics experience is preferred, as well as knowledge of the IVD regulatory environment in USA and Europe.
  • Experience with Quality System and Design Control regulations, specifically ISO 13485 or ISO 9001, and FDA QSR 21 CFR Part 820.
  • Knowledge of the preparation, submission and presentation of information to support various regulatory processes, such as 510 (k) Pre-Submissions and submissions, and the preparation of technical files to support CE marking.
  • Experience in interacting with regulators and auditors.
  • Background/familiarity in FDA regulatory pathways, in particular for Class II IVDs (traditional, de novo, and special 510(k)). Experience with Class III (PMA) is an advantage.
  • Strong analytical, verbal and written communication skills.
  • Experience individually or as part of a team in molecular diagnostics, molecular diagnostics platforms, and multiplex biomarker assays is essential. Minimum 2-3 years of experience as a bench-level scientist is strongly desired.

SCOPE OF ACCOUNTABILITY

  • Works with cross-functional teams at Immunexpress to ensure regulatory compliance.
  • Prepares, submits and maintains domestic and international regulatory submissions.
  • Assumes a collaborative role in directing the regulatory approval strategy for all products ensuring internal agreement on direction and activities.
  • Assists the Director of Commercialization Programs with strategic direction, oversight and management of the Regulatory Compliance function aligning department and project objectives with overall corporate objectives.
  • Collaborates with a variety of internal and external scientific and medical experts to provide input into and support regulatory compliance in the company’s research and development pipeline.
  • Monitors the global regulatory environment to assist in the development of optimal global regulatory strategies for all phases of clinical development.
  • Oversees review of labelling and advertising materials for compliance with regulations; analyzes and recommends appropriate changes.
  • With the Product Development and the Quality teams, plans, schedules, and conducts quality audits of contracting laboratories and collaborators performing clinical testing for Immunexpress. Documents audit observations, evaluates impact, and makes recommendations for corrective actions. Evaluates responses to audit findings and ensures that appropriate corrective actions are completed.
  • Responsible for obtaining/maintaining required certifications necessary for business operations under state, federal and local regulations.
  • With the Product Development and the Quality teams, develops and implements Quality Assurance, Quality Audits, Compliance and Management for the organization.
  • Ensures compliance with federal and state laws and regulations specific to safety and laboratory testing procedures. Reviews regulations and industry trends to ensure laboratory and company procedures are current.

DESIRABLE TRAITS AND SKILLS

  • Independent and motivated with a hands-on approach; able to deal with pressures and timelines inherent in an ambitious company that is driving its programs to completion.
  • Ability to influence and work with personnel at all levels and functional boundaries and represent Regulatory Affairs in multiple contexts (e.g. R&D, Product Development, Marketing, Clinical Trials, Quality).
  • Strong communication skills and demonstrated ability to build relationships and act as liaison with regulatory agencies and partners on various matters.
  • Able to deal effectively with government regulatory agencies, auditors, consultants, suppliers and customers.
  • Decisive and willing to take charge in developing consensus without alienating others. Must have strong team skills and be able to work across many organizational units equally well.
  • Ability to prioritize, organize and perform in a fast-paced, dynamic and demanding environment.
  • Must possess skills which span science and business and be capable of instilling confidence and pride throughout the Company.
  • Play a key role in maintaining the strong partnership between all functional areas.