Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.
Lead QMS and regulatory remediation to align global procedures with FDA QMSR and ISO 13485.
Manage global regulatory submissions and interactions with Notified Bodies for EU MDR, UKCA, and other markets.
Serve as RA representative on core project teams for hardware and AI/software releases.
Eko Health develops AI-powered digital stethoscopes and ECG tools to help clinicians detect heart and lung disease. The company is venture-backed, recognized by TIME as a top healthtech company, and has a mission-driven team of engineers, physicians, and creatives.
Conduct technical and clinical assessments of non-active orthopaedic devices under EU MDR 2017/745 and UK MDR 2002.
Support CE and UKCA marking, ensuring compliance and minimizing regulatory risks for device certification.
Communicate with stakeholders, train junior staff, and manage schedules to deliver timely assessments.
SGS is a world-leading testing, inspection and certification company focused on quality and integrity. Our 99,600 employees in 2,600 offices enjoy a dynamic, international culture with strong development opportunities.
Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs.
Lead key regulatory submissions including INDs, CTAs, and DMFs.
Serve as primary contact for regulatory agencies and build strong relationships with health authorities.
ARTBIO discovers and develops a new class of Alpha Radioligand Therapies (ARTs) to redefine cancer care. It is a global biotech with offices in Boston, Basel, London, and Oslo, fostering a collaborative and supportive culture.
Manage business operations for multiple scientific teams in the Pacific Northwest, including Washington and Colorado.
Lead direct reports, group leaders, and teams, and serve clients in technical settings like laboratories.
Collaborate with clients to meet resourcing needs, ensure high-quality service, and handle financial responsibilities as defined by the Director.
Eurofins Scientific is an international life sciences company providing analytical testing services to ensure safety and sustainability across industries. With 58,000 staff and 900 laboratories in over 54 countries, it operates as a decentralized and entrepreneurial network, offering over 200,000 testing methods.
Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.
Oversee quality compliance for combination products, ensuring regulatory standards and company objectives are met.
Develop and implement quality strategies in collaboration with cross-functional teams and external partners.
Stay current with global device and combination product regulations, supporting audits and design control oversight.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, the company fosters a culture of empathy, urgency, and an owner's mindset.
Support the development and execution of clinical regulatory strategies for assigned programs across regions.
Prepare and manage IND applications and other regulatory submissions, ensuring accuracy and timely delivery.
Provide regulatory guidance to cross-functional teams and participate in health authority interactions.
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.
Provides strategic and scientific leadership for patient-centered outcomes engagements, ensuring research design and evidence packages are fit-for-purpose.
Owns client relationships, drives business development, and leads proposal development to achieve revenue and sales targets.
Oversees clinical outcome assessment projects including literature reviews, gap analyses, regulatory strategy, and dossier development.
Lumanity is a global strategic partner that brings together strategy, evidence, engagement, and technology to improve health outcomes. The company is dedicated to accelerating and optimizing access to life-changing medicines.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.
Define and own ONI's bioprocessing market strategy, including priority segments and routes to market.
Establish ONI as a valued analytical partner across bioprocess development and characterization workflows.
Drive portfolio priorities, strategic partnerships, and commercial enablement to deliver measurable adoption.
ONI develops the Nanoimager, a super-resolution microscope that enables scientists to visualize and understand biological processes at the molecular level. The company fosters an inclusive, flexible culture with competitive benefits and a focus on groundbreaking research.
Lead clinical trial strategies and evidence-generation plans supporting global regulatory submissions.
Design and oversee clinical protocols, claims, and evidence strategies in collaboration with internal and external stakeholders.
Serve as a scientific liaison with regulatory authorities and mentor junior scientists to drive clinical excellence.
The company develops diagnostic products for the US and EU markets, focusing on generating robust clinical evidence for regulatory submissions. It maintains a remote-first culture with a collaborative, cross-functional environment and opportunities for scientific leadership.
Develop and lead integrated global regulatory strategies for I&I pipeline programs.
Serve as primary regulatory strategist and Health Authority relationship lead.
Provide expert guidance on development plan design and filing strategies.
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. It is a small company backed by world-class investors, with a culture of scientific rigor and operational excellence.
Drive strategic growth of Celerion's Bioanalytical Services business through new client acquisition in biologics, biomarkers, and emerging therapeutic modalities.
Serve as a technical commercial leader combining scientific credibility with consultative selling to develop new client relationships.
Collaborate with regional Business Development teams and manage a national opportunity pipeline to expand presence with biotech and pharma companies.
Celerion is a clinical research organization that accelerates drug development through translational medicine and innovative research strategies. The company values integrity, trust, teamwork, and respect, operating with experienced professionals across the US.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Handle highly complex customer and employee inquiries across the APAC region using remote service tools.
Promote digital service tools and conduct technical and digital training for customers and internal staff.
Serve as a mentor for new team members and lead regional service-related projects within the agile Hub environment.
Roche is a global healthcare company advancing science to prevent, stop and cure diseases, ensuring everyone has access to healthcare. With over 100,000 employees worldwide, Roche fosters an inclusive culture that values personal expression, open dialogue, and genuine connections.