Mirrai Careers

Senior Manager, Regulatory Affairs

Adaptive Biotechnologies

Remote (WFH) Remote Posted 5d ago
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At Adaptive, we’re Powering the Age of Immune Medicine.  Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated. As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application. It’s time for your next chapter. Discover your story with Adaptive.   Position Overview The Senior Manager, Regulatory Affairs leads the development and execution of ex-US regulatory strategy for the company's NGS-based in vitro diagnostic (IVD) products, with a starting focus on the EU In Vitro Diagnostic Regulation (IVDR) and Health Canada, expanding over time to additional priority markets (e.g., UK/UKCA, Australia/TGA, China/NMPA, and other geographies as the international footprint grows). This role also owns the regulatory relationship with biopharma partners for companion diagnostic (CDx) and complementary diagnostic co-development programs, and maintains working knowledge of the US regulatory framework (FDA) to ensure a cohesive, globally aligned regulatory strategy. This individual will be a key strategic partner to the VP, Regulatory & Quality as the company builds out its clinical program, and will help shape international clinical and regulatory pathways for future NGS-based clinical trials and CDx submissions. Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. Critical functions of your role include helping establish individual team member goals, aligning those individual goals with broader team objectives, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at Adaptive create an environment of belonging, respect, and open and honest communication every day. Key Responsibilities and Essential Functions International Regulatory Strategy * Own and evolve the company's ex-US regulatory strategy, prioritizing EU IVDR (technical documentation, Notified Body engagement, serve as PRRC, EU Declaration of Conformity) and Health Canada (Medical Device License applications, License amendments, Class III/IV IVD requirements) as the initial core markets. * Build the regulatory roadmap for future international expansion (e.g., UKCA, TGA, NMPA, other APAC/LATAM markets), including market-entry sequencing, gap assessments, and localization requirements. * Serve as primary point of contact and lead negotiator with international regulatory authorities and Notified Bodies; plan and lead regulatory agency/Notified Body meetings with support of the internal Regulatory leadership. * Monitor global regulatory intelligence (IVDR amendments, Health Canada guidance, IMDRF harmonization efforts, etc.) and translate changes into actionable strategy and internal process updates. * Own and maintain international technical files, design dossiers, and post-market surveillance/vigilance reporting obligations in coordination with Quality. Biopharma & Companion Diagnostics * Serve as the regulatory lead for biopharma co-development and companion diagnostic partnerships, aligning CDx regulatory strategy with partner drug development timelines (US and international). * Represent the company in regulatory discussions with biopharma partners and, where applicable, joint health authority interactions related to CDx submissions. * Provide regulatory input into companion/complementary diagnostic labeling, indications for use, and co-development agreements. * Support integration of CDx regulatory requirements into NGS assay development and clinical validation planning. US Regulatory Foundation & Cross-Functional Alignment * Maintain working knowledge of US FDA pathways relevant to NGS IVDs (510(k), De Novo, PMA, and CLIA/LDT considerations) to ensure international strategy remains harmonized with the US regulatory approach. * Partner with the Regulatory team to align global submission content, labeling, and change control assessments across regions. * Support the internal Regulatory leadership in building out the company's clinical program — providing regulatory input on international clinical trial requirements (e.g., EU/Health Canada clinical performance study requirements, ethics committee coordination) for NGS assays and CDx studies. Leadership & Cross-Functional Collaboration * Mentor and provide technical/strategic guidance to junior Regulatory team members. * Partner closely with R&D, Quality, and other teams to ensure regulatory considerations are embedded early in product development and lifecycle management. * Represent Regulatory on cross-functional product development and lifecycle teams; communicate risk assessments and mitigation plans to leadership. * Contribute to departmental budgeting, resourcing, and process/SOP development for international regulatory operations. All other duties as assigned Position Requirements (Education, Experience, Other) Required Qualifications * Bachelor's degree in a life sciences, engineering, or related scientific discipline; advanced degree (MS, PhD, or equivalent) preferred. * 12+ years of progressive regulatory affairs experience in IVD, molecular diagnostics, medical device, or biopharmaceutical industries, including direct, hands-on experience with EU IVDR technical documentation and Notified Body submissions and Health Canada Medical Device License applications. * 2+ years of supervisory experience * Demonstrated experience developing and executing global/international regulatory strategy across multiple product lines or markets. * Working knowledge of US FDA regulatory frameworks for IVDs (510(k), De Novo, PMA) and CLIA/laboratory-developed test considerations. * Experience interfacing directly with regulatory authorities and/or Notified Bodies, including leading agency meetings and submission negotiations. * Strong knowledge of quality system frameworks relevant to IVDs (ISO 13485, ISO 14971, IEC 62304 for software as a medical device). * Excellent written and verbal communication skills, with experience presenting to senior leadership and external partners. * Proven people leadership or matrixed team leadership experience, with the ability to mentor and develop regulatory staff. Preferred / Desired Qualifications * Direct experience supporting biopharma companion diagnostic co-development programs, including joint submissions or partner-facing regulatory strategy. * Clinical trial, clinical affairs, or clinical research regulatory experience (e.g., IDE submissions, clinical performance studies, GCP-related regulatory support) — desirable as the company builds out its clinical program. * Experience with additional international markets beyond IVDR/Health Canada (UKCA, TGA, NMPA, or other APAC/LATAM frameworks). * Familiarity with data privacy/genomic data considerations relevant to international markets (e.g., GDPR). Working Conditions Office environment, domestic and international travel required (estimated 10%) to support regulatory agency meetings, Notified Body audits, and biopharma partner engagements as needed. #LI-Remote ----------------------------------------   Compensation Salary Range: $144,600 - $217,000   Other compensation elements to include: * equity grant * bonus eligible     ---------------------------------------- ALERT: Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment.  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 is not currently sponsoring candidates requiring work authorization support for this position. Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives. ---------------------------------------- Adaptive's benefits at-a-glance. Adaptive Biotechnologies is an Affirmative Action and 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 based on disability. Please refer the “Know Your Rights: Workplace Discrimination is Illegal” Poster for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email [email protected]. If you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please e-mail [email protected]. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. 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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