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.
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.
Audit medical records to ensure documentation supports level of service and compliance with coverage determinations.
Develop and implement educational programs for coding and documentation improvement.
Orient and audit newly on-boarded providers and programs.
Southcoast Health is a not-for-profit health system providing comprehensive healthcare across Southeastern Massachusetts and Rhode Island. With multiple facilities, they have been voted 'Best Place to Work' for 7 years in a row.
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.
Serve as a key subject matter expert on Medicare, Medicaid and drug pricing policy issues impacting the pharmaceutical/biotech, health insurance, pharmacy, and PBM industries.
Generate both strategic and tactical recommendations for clients that are responsive to their policy and business needs.
Lead the day-to-day execution of projects and engagements with clients, including managing a project team and ensuring quality delivery.
Avalere Health is a healthcare advisory, medical, and marketing firm focused on ensuring every patient is identified, treated, supported, and cared for. The company has global offices and fosters an inclusive culture with employee network groups and flexible working arrangements.
Own regulatory review and approval of promotional materials across HCP, DTC, digital, and social channels, ensuring compliance with FDA regulations.
Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims, providing clear guidance to reduce approval delays.
Lead FDA promotional submissions, monitor regulatory trends, and build scalable processes to support product launches.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company values Trust, Ownership, Curiosity, and Results, and offers a collaborative, high-achieving environment with a focus on diversity and inclusion.
Manage third-party and FDR oversight, including due diligence, risk tiering, and ongoing monitoring.
Lead privacy and security incident response, including breach risk assessment and reporting.
Administer compliance program, including drafting policies, presenting training, and conducting internal audits.
Evermore is a technology company that administers Smart Benefits to connect people to products and services they need. It is a Series B stage company backed by leading investors, fostering a culture of innovation and health equity.
Lead analytical strategies for commercial products, ensuring compliant and robust methods and specifications.
Manage method transfers, validations, and lifecycle activities while collaborating with CDMOs and cross-functional teams.
Contribute analytical expertise to regulatory submissions and support health authority inspections.
The company is a science-driven biopharmaceutical organization focused on developing and commercializing small-molecule drugs. They foster a collaborative culture with engaged colleagues and emphasize scientific excellence.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Monitor operational activities for compliance with healthcare policies and established procedures
Support compliance reviews of billing, coding, claims, and documentation processes
Assist with internal audits, compliance assessments, and corrective action plans
Raventra Health is a medical services company providing outsourced billing, coding, and claims processing solutions for provider groups and hospitals. The company's size and culture are not specified in the posting.