- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the operations department to setup… more
- Philips (New Kensington, PA)
- …through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and global standards; manage project execution in alignment ... Minimum of 8+ years of professional experience in product/solution development within FDA -regulated medical device or technology sectors. + Minimum of 8+ years… more
- Sumitomo Pharma (Harrisburg, PA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA filings. +… more
- Cardinal Health (Harrisburg, PA)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and approvals),… more
- Legrand NA (Canonsburg, PA)
- …control practices comply with industry standards such as ISO 9001, FDA , and other relevant regulatory requirements. + Continuous Improvement Initiatives:Identify ... of document control systems and industry standards such as ISO 9001, FDA , or GMP. + Demonstrated leadership and project management skills. + Exceptional… more
- West Pharmaceutical Services (Exton, PA)
- …as well as regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. + Create and maintain system lifecycle documents in accordance with West ... as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. **Preferred Knowledge, Skills and Abilities** + Deep expertise, understanding… more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. * Attend… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …+ Organize and validate device data for submission and registration with the FDA GUDID database. + Assist with customer order approvals, including medical devices ... within the medical device or pharmaceutical industry. + Strong understanding of FDA regulations, as well as state and international regulations related to medical… more
- Merck (Harrisburg, PA)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... Cattle, Biopharmaceuticals, Cattle Feeding, Cattle Production, Customer-Focused, Data Analysis, FDA Regulations, Feedlots, Field Sales Support, Livestock Management, Nutritional… more
- TreeHouse Foods, Inc. (Lancaster, PA)
- …. Serve as the plant's liaison for regulatory authorities, including USDA, FDA , and third-party auditors. **_Important Details:_** . This is a full-time, on-site ... food manufacturing environment. . In-depth knowledge of sanitation practices, GMPs, FDA /USDA regulations, and third-party audits. . Hands-on experience with GFSI… more