Support regulatory and quality processes to ensure compliance with applicable requirements, focusing on product design, development, and manufacture of medical devices.
Assist in drafting regulatory submissions for domestic and worldwide commercialization and provide guidance on product labeling and lifecycle planning.
Evaluate regulatory impact of changes, manage product recall activities, and participate in internal and third-party quality audits.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
Partner with Regulatory leads to manage regulatory filing subteams and subteam operations.
Develop and maintain high level and detailed regulatory timelines that utilize project management software tools.
Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays.
Ultragenyx is a biopharmaceutical company committed to addressing unmet medical needs in the field of rare diseases. With a focus on innovation and patient-centricity, they strive to develop life-changing treatments and improve the lives of patients and caregivers.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.
Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Build and scale the "Technical Playbook" for medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Hims & Hers is a health and wellness platform committed to better health by offering affordable and personalized care. As a public company traded on the NYSE, they are normalizing health & wellness challenges and innovating on their solutions to make better health outcomes easier to achieve.
Manages complex cross-functional design and development projects on a first in class wearable device.
Works with cross-functional team to ensure timely and complete deliverable execution.
Identifies, analyzes, and tracks project risks and issues and monitors progress to plan.
Cognito Therapeutics, Inc. translates scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. They are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world.
Receive and review complaints related to medical devices.
Communicate directly with customers to solicit information, address concerns, and provide updates on complaint resolution.
Collaborate with cross-functional teams to resolve complaints.
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Their team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience.
Develop and execute medical affairs strategies aligned with company goals.
Build and maintain strong relationships with HCPs, KOLs, and patient advocacy organizations.
Collaborate with the CMO to establish high-integrity, compliant processes for HCP and KOL engagement.
Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. Every program reflects their commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
Drafts and maintains medical information content for the Medical Information Call Center (MIC).
Provides guidance to Medical Information Managers on drafting standard medical responses and FAQs.
Reviews MIC case records to ensure accuracy of response and compliance with regulations.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for serious diseases. The company is consistently recognized as one of the industry's top places to work, with a diverse and inclusive culture.
Contribute to the design of early/late-stage protocols across multiple therapeutic areas.
Develop and write statistical analysis plans, and perform statistical analyses for interim and final reports.
Support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, they focus on quality, professional development, and a supportive culture.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Responsible for CMC regulatory activities globally for assigned projects and adapts swiftly to changing events and priorities.
In charge of CMC strategy development, with management support, for CMC submission dossiers to support lifecycle management.
Ensures that information submitted in support of life cycle maintenance applications meets regional requirements, allowing maximum flexibility in supply, manufacturing and quality.
Alphanumeric recruits for one of the largest pharmaceutical companies in the world, headquartered in Montreal, Quebec. They are helping them find a Responsable des affaires réglementaires internationales CMC to work remotely in Quebec or Ontario.