- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs , Tactical Implementation, on the Regulatory ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Dentsply Sirona (Milford, DE)
- …enhancing business relationships. Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, ... degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. ...regulatory projects. In-depth knowledge of FDA 510(k) and international regulations (eg, EN ISO 13485, EU MDR). Experience… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and connected technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning ... medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class ...Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will ... comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device...Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager , Clinical Research Regulatory Affairs is tasked ... with oversight and governance of Regulatory Affairs department and involved in the day-to-day support of the clinical research studies conducted at Children's… more
- Olympus Corporation of the Americas (Westborough, MA)
- …responses to regulatory or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of dossiers for ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health...registration on for other international markets such as Japan, Middle East and Africa,… more
- Teleflex (Houston, TX)
- …REQUIRED: 50% (Domestic and International ; overnight required)** The Clinical Affairs Manager will provide clinical expertise, insight, and support to ... Clinical Affairs Manager , Interventional Access (REMOTE) **Date:**...ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Teleflex complies.… more
- Lundbeck (Deerfield, IL)
- Senior Director Medical Affairs , Movement Disorders Requisition ID: 7172 Location Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the...policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Manager , Global Medical Affairs Omnichannel Content is responsible for the development, approval, and delivery of ... GMA Omnichannel and Digital Content Lead and team, the Senior Manager will support the end-to-end content lifecycle-including planning, development, review,… more
- Lundbeck (Deerfield, IL)
- Senior Director Medical Affairs , Movement Disorders Requisition ID: 7172 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the...policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a… more
- Endo International (St. Louis, MO)
- …Teams **RELATIONSHIP WITH OTHERS:** Reports to the Sr Director, Quality and Regulatory Affairs . Manages group of exempt direct reports. Develops strategic ... basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations. + Knowledge of US and International … more
- Hawaiian Electric (Honolulu, HI)
- …Electric Companies, including in operations, engineering, planning, community relations, and regulatory affairs . + Evaluates and selects large complex or ... Manager , Energy Procurement - Oahu Date:Nov 21, 2025...Planning and Technology, Energy Delivery, System Operation, Power Supply, Regulatory , Government and Community Relations, and Legal to optimize… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** Manager , Quality Assurance External Manufacturing is responsible for managing… more
- Lilly (Lebanon, IN)
- …as a liaison between construction teams, manufacturing operations, engineering, and regulatory affairs to ensure alignment and timely decision-making. Develop ... construction activities adhere to Good Manufacturing Practices (GMP) and regulatory requirements for radiopharmaceutical production. Manage internal and external… more
- FM (Johnston, RI)
- …same in support of the provision of technical advice and recommendations to Corporate Affairs Counsel, the Manager , Corporate Affairs , and internal business ... of Corporate Affairs matters including: - Contract review - Legal, regulatory , compliance, risk, and corporate governance matters - Corporate regulatory … more
- Olympus Corporation of the Americas (Westborough, MA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... **Job Description** This role collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and oversee aspects of clinical… more
- Eisai, Inc (Nutley, NJ)
- …Medical, Market Access, Corporate Advocacy, HR, IT, Data Governance, Government Affairs , R&D, etc.) in executing both high-priority strategic initiatives (eg, ... and collaborate with global privacy counterparts to ensure compliance with international frameworks (eg, GDPR, PIPEDA) and alignment on enterprise-wide privacy… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... methodology and procedures that comply with applicable domestic and international regulatory laws/standards and all developed Olympus...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... and go-to-market frameworks tailored to dermatologists treating HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical and research… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Strong cross-functional collaboration experience, including working with Legal, Compliance, Regulatory , Medical Affairs , and Clinical Operations. Familiarity ... in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. Other duties as assigned.… more
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