- Novo Nordisk (Plainsboro, NJ)
- …or medical device/pharmaceutical combination product experience and actual regulatory experience + Advanced knowledge of pertinent FDA regulations ... within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education… 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 in ... project team meets US requirements in development activities. The manager will be responsible for FDA meetings...accordance with the project governance model to drive Target Product Profile objectives. + Provides consistent regulatory … more
- Abbott (Santa Clara, CA)
- …to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently to ... CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve...regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class… more
- Abbott (Sylmar, CA)
- …Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management Business. This ... regulatory strategies, submissions to support clinical trial activities and product launches. This individual applies advanced regulatory expertise to guide… more
- AbbVie (San Francisco, CA)
- …compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). This ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & Canada position is… more
- Hologic (Marlborough, MA)
- …looking for a Regulatory Affairs Manager , responsible for on-market regulatory activities associated with US FDA , EU Notified Body, and other ... Manager , Regulatory Affairs (IVD On-Market/Sustaining) San...advice to senior management on strategies and plans for regulatory product approvals and on-market regulatory… more
- Stryker (Mahwah, NJ)
- We are currently seeking a **Senior Manager , Regulatory Affairs** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, ... Weston, FL with some workplace flexibility. As the **Senior Manager , Regulatory Affairs** , you will lead...will do** + Direct and coordinate activities of experienced Regulatory Affairs professionals to support total product … more
- Takeda Pharmaceuticals (Boston, MA)
- …the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs, Marketed Products **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs, Marketed Products with...product development plan(s) and build into global integrated regulatory strategy. Up to 75% remote work is allowed.… more
- ITW (Rogers, MN)
- …with exceptional opportunities for personal and career development. We are seeking a Regulatory Compliance Manager whose primary role is to ensure that all ... product lifecycle. Responsibilities: + Monitor, interpret, and implement regulatory all environmental, health and safety standards applicable to industrial X-ray… more
- Kelly Services (Valencia, CA)
- …two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product registrations, certifications, ... + ** Regulatory Affairs Manager ** + **Location:** Onsite...+ Proven experience with 5 years or more of FDA submissions and international regulatory compliance. +… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Manager , Regulatory Compliance - Shockwave Medical** to join our team located in ... pressure waves for the treatment of calcified plaque. **JOB SUMMARY** The Regulatory Compliance Senior Manager provides key strategic insight, direction, and… more
- Abbott (Alameda, CA)
- …monitor their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager ** will work on-site in Alameda, CA for our ... glucose levels with our new sensing technology. As the Regulatory Affairs Manager , you will combine your...develop and manage regulatory professionals. + Provide regulatory input to product lifecycle planning. Monitor… more
- Bausch Health (Bothell, WA)
- …well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global product ... itwhere your skills and values drive our collective progress and impact. The Manager , Regulatory Affairs will be responsible for: + Responsible for developing… more
- Bausch Health (Bothell, WA)
- …regulatory submissions for product change updates, extensions, or modifications to regulatory bodies (eg, FDA , EMA). + Ensure that regulatory ... and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to...throughout the product lifecycle. About the role: Product Lifecycle Management + Oversee the regulatory … more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager ** position is an onsite opportunity working out ... expert resource and mentor within the department. **WHAT YOU'LL DO** + Provide regulatory input to product lifecycle planning. Provide strategic input and… more
- Amazon (Seattle, WA)
- …will manage several Pharmacists in Charge within a geographic region. The Senior Manager Regulatory Ops is responsible for maintaining adherence to regulatory ... Description Amazon Pharmacy is seeking a Senior Manager , Regulatory Operations who is dedicated...to our customers. You will engage compliance, legal, finance, product , design, and engineering teams in an efficient and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market ... in the markets served by Olympus. **Job Duties** + Facilitate development of regulatory strategy for novel technologies or market segments, that lead to product… more
- Kentucky Blood Center (Lexington, KY)
- …not be considered. Kentucky Blood Center is seeking a qualified Quality Assurance Manager to guide and support organizational adherence to standards issued by ... regulatory agencies and accrediting organizations. The position is responsible...position is responsible for KBC's compliance with applicable AABB, FDA , CLIA, State, OSHA, EU, and short supply agreement… more
- ThermoFisher Scientific (Austin, TX)
- …Office **Job Description** **Responsibilities:** Join Thermo Fisher Scientific Inc. as a Manager , Regulatory Affairs, and play a pivotal role in molding ... regulatory guidance to project teams + Document regulatory strategies for product submissions. + Facilitate...for Next Generation Sequencing and/or PCR assays + Facilitate FDA pre-submission meetings + Prepare US regulatory … more
- Tecomet (Manchester, NH)
- **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 CFR | Part ... 820, ISO 13485, ISO 14971, AS9100, and applicable regulatory standards. This role manages Quality Engineering and Inspection teams, leads audits, coordinates… more
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