- Abbott (Santa Clara, CA)
- …units that Leverage Services team supports, including the execution of strategic regulatory initiatives, regulatory submissions , agency relationship and ... leadership experience to support the medical device business units with their regulatory submissions . Collaborates closely with internal regulatory … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. This could include… more
- Sumitomo Pharma (Lincoln, NE)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... PMA submissions a plus + Experience assessing regulatory impact of product/process changes + Experience reviewing labeling, promotional literature, etc. +… more
- Medtronic (Los Angeles, CA)
- …for new and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS) geographies. ... portfolio and regulatory and quality system procedures. + Prepare regulatory submissions for new products and product changes, as required, to ensure timely… more
- Fresenius Medical Center (Waltham, MA)
- …pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions . + Collaborate with senior leadership in ... and potential risks to inform decision-making across the organization. + **Global Regulatory Submissions :** + Oversee the planning, preparation, and execution of… more
- AbbVie (Irvine, CA)
- …maintenance of chemistry, manufacturing, and controls (CMC) device sections of regulatory submissions , responses to Agency questions for worldwide registration ... care medicinal delivery products. Responsibilities: + Develops and prepares pre-market regulatory submissions . Demonstrated success in directly securing … more
- System One (Florham Park, NJ)
- … information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions . + Maintain knowledge of local regulatory ... DMF). + Ensure consistency across regulatory submission documents following the regulatory style guide (ie formatting, reviewing, and submissions ). + Provide… more
- Medtronic (Irvine, CA)
- …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing… more
- AbbVie (Waltham, MA)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more