- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... At Globus Medical , we move with a sense of urgency...their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting… more
- Merck (North Wales, PA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... brochures + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD)… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting...experience + 5+ years of related experience in the medical device industry + Understanding of regulatory … more
- CVS Health (Pittsburgh, PA)
- …Management and internal/external stakeholders including CVS Audit Team, Legal, Compliance and Regulatory Affairs . + Collaborate in a matrixed environment with ... regulations. + Support PBM market conduct examinations, CMS audits, and internal regulatory reviews. + Partner with Government Affairs , Legal, and Compliance… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- Pfizer (Collegeville, PA)
- …Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, at least 8 years. + ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs more
- Sumitomo Pharma (Harrisburg, PA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... the Regulatory reviewer for assigned products. This position is responsible...materials, eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of… more
- Merck (North Wales, PA)
- …we are the right company for your long-term goals **Team Overview:** The Global Regulatory Affairs and Clinical Safety (GRACS) Regulatory Digital Health ... (RDH) team assists in bringing new medical advancements to the world by facilitating communications and...across the product portfolio. + Build familiarity with Global Regulatory Affairs and Clinical Safety systems enabling… more
- Constellation (Pottstown, PA)
- …Effective written and oral communication skills + Approval of VP Licensing & Regulatory Affairs required to obtain this classification (and recommendation of ... program, 401(k) with company match, employee stock purchase program; comprehensive medical , dental and vision benefits, including a robust wellness program; paid… more
- Organon & Co. (Plymouth Meeting, PA)
- …Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well as ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
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