- Olympus Corporation of the Americas (Westborough, MA)
- …solutions in collaboration with functions across the business. + Deep experience in regulatory compliance for digital health software not classified as medical ... Core Regulatory Affairs Team and provides world-class regulatory strategies for digital health solutions, ensuring compliance...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Minimum of 3 years focused on software-driven health technologies. + Experience with regulatory compliance for digital health software not classified as medical ... the medical device classification, and connected technologies. + Provide regulatory guidance, compliance risk assessment, and strategic...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize… more
- Parexel (Boston, MA)
- …- Work on impactful global programs that directly support patient safety and regulatory compliance . - Collaborate with a diverse, international team across ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting… more
- Olympus Corporation of the Americas (Westborough, MA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... and supporting submissions or audits. + Understanding of global digital health regulatory landscapes and voluntary compliance schemes. + Effective communicator… more
- Integra LifeSciences (Braintree, MA)
- …Quality Metrics-and plays a critical part in ensuring ongoing regulatory compliance across site operations. The Associate Manager will also support external ... outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Associate Manager , Quality Compliance supports the development, maintenance, and continuous… more
- Skanska (Boston, MA)
- …integration of environmental health & safety services into the business practices and compliance with regulatory requirements on their assigned Project. The EHS ... searching for a dynamic Environmental Health & Safety (EHS) Manager . This is a great opportunity to start a...manager shall be project based. The EHS manager oversees responsibilities of their assigned Project as related… more
- Commonwealth Care Alliance (Boston, MA)
- …understanding of Medicare, Medicaid, duals program, and health plan operations, including regulatory and compliance requirements. - Demonstrated knowledge of DMH ... CA-Provider Engagement & Performance Position Summary: The Provider Delegation Performance Manager is responsible for overseeing and improving the performance of… more
- Commonwealth Care Alliance (Boston, MA)
- …of Medicare, Medicaid (MassHealth), and dual-eligible program operations, including regulatory and compliance requirements. - Demonstrated ability to ... Position Summary: The Behavioral Health (BH) Provider Engagement Program Manager is responsible for cultivating strong, collaborative relationships with behavioral… more
- Red River (Lexington, MA)
- …continuous improvement through ITIL-aligned best practices + Maintain SOPs and ensure regulatory compliance + Champion quality and operational efficiency across ... seek to make those around you successful. **We are seeking a seasoned** **Program Manager - ITSM** **to lead the delivery of managed services for a high-profile… more
- Parexel (Boston, MA)
- …members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance . **About the Role** As a **Senior Physician in ... regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event… more
- Parexel (Boston, MA)
- …leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. ... to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal… more
- Commonwealth Care Alliance (Boston, MA)
- … Manager , to keep providers informed of organizational objectives, regulatory updates, operational changes, and compliance requirements. - Establish ... relationships with key healthcare providers, optimizing network performance, and ensuring compliance with regulatory standards. The Director drives initiatives… more
- Olympus Corporation of the Americas (Westborough, MA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus's… more
- Olympus Corporation of the Americas (Westborough, MA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... to improve Olympus compliance profile. + Monitors plans and applies Global regulatory or Olympus requirements into the QMS regionally and at the local level… more
- Parexel (Boston, MA)
- …Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager . ** Compliance with Sponsor Standards** + Ensures compliance with ... monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... managing the creation and execution of Human Factors documentation to ensure compliance with regulatory requirements in alignment with the business strategy… more
- Olympus Corporation of the Americas (Westborough, MA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... + Strong cross-functional collaboration experience, including working with Legal, Compliance , Regulatory , Medical Affairs, and Clinical Operations. +… more
- Commonwealth Care Alliance (Boston, MA)
- …serves as a key liaison, proactively addressing provider needs, ensuring regulatory compliance , and supporting operational excellence to enhance provider ... educating on CCA's policies, program benefits, billing, referral and authorizations regulatory compliance , and contractual expectations. Conduct orientation and… more
- Parexel (Boston, MA)
- …monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and ... countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation,… more
- Parexel (Boston, MA)
- …the quality of investigator sites (eg patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, ... coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide...(DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study… more