- Lundbeck (Deerfield, IL)
- … Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory ). **REQUIRED EDUCATION, EXPERIENCE AND SKILLS:** + Accredited ... certifications. + Global Regulatory Affairs Experience. + Exposure to international regulatory affairs, including participation in submissions to ex-US… more
- GRAIL (Atlanta, GA)
- …for compliance and regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that may significantly impact ... with strong business partnering skills. + Demonstrated knowledge of US and international regulatory frameworks and processes for medical device development and… more
- Post Holdings Inc. (St. Louis, MO)
- …direct the legal aspects of all FDA, USDA, State Attorneys General, and international regulatory authority related matters + Provide counsel, training and ... and assist as a liaison between the company and regulatory authorities + Oversee legal aspects of all ...cross-functional teams to assure compliance with applicable domestic and international laws and regulations + Provide guidance and leadership… more
- Olympus Corporation of the Americas (Westborough, MA)
- …to regulatory or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of dossiers for registration ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ...on for other international markets such as Japan, Middle East and Africa,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …is desirable. + Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a Medical Device highly desirable. ... . **Job Description** This role is responsible for coordinating and managing regulatory activities across the Digital Unit (DU). The Digital Unit is a… more
- Olympus Corporation of the Americas (Westborough, MA)
- …connected technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning considerations ... This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU is a high-growth,… more
- Insmed Incorporated (NJ)
- …strongly preferred.A background in providing product defense before a national or international regulatory authority is a plus.Experience within the rare disease ... completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible,… more
- Insmed Incorporated (NJ)
- …required documentation. Ensuring compliance with ICH, FDA, EMA, PMDA and other international regulatory guidelines will be essential to your success.You will ... a strategic leader, ensuring that development programs meet scientific, quality, regulatory , and commercial standards, while ensuring execution across internal teams… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …internal methodology and procedures that comply with applicable domestic and international regulatory laws/standards and all developed Olympus policies and ... Global Vice President QARA Compliance provides assurance and manages all aspects of Regulatory Compliance. The focus will be over the implementation of the Global… more
- Merck & Co. (Durham, NC)
- …GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements Knowledge of Quality Systems within a ... methods Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable Experience with hosting or participating… more
- Insmed Incorporated (NJ)
- … regulatory submissions across multiple regions (US, EU, and/or other international markets)Strong knowledge of global regulatory requirements and submission ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Lundbeck (Deerfield, IL)
- …sign-off authorization. + Ensures all activities are following ICH, and other international regulatory guidelines and relevant GCPs and SOPs. + Participates ... thought leaders. + Professional society membership(s) relevant to migraine/headache. + Regulatory knowledge and exposure, including experience with international … more
- Merck & Co. (Durham, NC)
- …and change requests. Acts as a participant in domestic and international regulatory agency inspectionsSupporting all quality and safety initiativesProvide ... Process Simulation, Product Formulation, Quality Assurance Processes, Quality Operations, Regulatory Submissions, Risk Assessments, Risk Control Assessment, Standard Operating… more
- Terumo Medical Corporation (Somerset, NJ)
- …full compliance with US Food and Drug Administration (FDA) regulations, international regulatory requirements, company policies, operating procedures, and ... position provides subject matter expertise in labeling requirements across US and international markets and ensures compliance with FDA, Terumo, and global … more
- Eisai, Inc (Atlanta, GA)
- …thorough understanding of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory /ethical guidelines relevant to the pharmaceutical industry & ... mentoring, performance management and talent review. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry,… more
- Terumo Neuro (Aliso Viejo, CA)
- …3. Strong knowledge of clinical trial processes and both US and international (OUS) regulatory requirements. 4. Excellent organizational, analytical, and ... team leadership, and strong cross-functional collaboration with Medical Affairs, PACE, Regulatory , Clinical Safety, and Data Management. Ensure high standards of… more
- Terumo Medical Corporation (Elkton, MD)
- …with all design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not ... of project and design. Responsible for contributing to the DHF and regulatory submittals, creating SOPs, and for providing training to ensure proper design… more
- Terumo Medical Corporation (Elkton, MD)
- …with all design control, quality, and company regulations and national and international regulatory body requirements for medical devices. This activity ... of project and design. Responsible for contributing to the DHF and regulatory submittals, creating SOP, and for providing training to ensure proper design… more
- Avnet (Chandler, AZ)
- …(ITAR), Export Administration Regulations (EAR) and all other local, national and international regulatory requirements. Will be managing the FTZ operations in ... + Monitors shipments subject to security regulations, both domestic and international , to ensure continual adherence to recordkeeping, reporting, tolling, and… more
- Terumo Neuro (Aliso Viejo, CA)
- …for third party audits including FDA, Notified Body, corporate and international regulatory authorities' audits. Supports follow-up efforts. + Prepares ... to maintaining and improving quality systems to ensure compliance with global regulatory requirements and ensuring that the quality systems are used effectively to… more
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