- 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
- 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
- Parexel (Columbia, SC)
- …- 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,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… 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
- 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
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... periods of time doing computer-based work + Extended hours to accommodate international / intercontinental global time schedules. + While performing the duties of… 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… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the… more
- CSL Behring (King Of Prussia, PA)
- …the guidance of the Publications Director, you will partner with Medical Affairs leaders, Compliance, Clinical, HEOR, and other functions to build efficient ... SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication...provide first line support for junior team members (eg manager and sr manager ) + Lead operational… more
- Bath & Body Works (New York, NY)
- …role is hybrid with the option to be located in NYC OR Columbus, OH* The International Regulatory Affairs Manager position will be responsible for ... compliance strategy for global market. This role, reporting to Principal, International Regulatory Affairs (Associate Vice President) is responsible for… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to… more
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