- System One (Plainsboro, NJ)
- Job Title: Regulatory Labeling Specialist Compensation: $95000 - $110000 annually depending on years of experience Location: Can be fully remote Employee ... individual also supports the systems and processes by which regulatory labeling items are created, approved, submitted...be responsible for managing projects, processes, or programs with manager oversight. + Knowledge of FDA and Health Canada… more
- Medtronic (Irvine, CA)
- …of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling , or an advanced ... to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online...+ Support the preparation of US and International promotional labeling material, including the creation of a claims matrix… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …project stakeholders at UCC, including stakeholders at multiple sites (eg, regulatory affairs, quality assurance, labeling , manufacturing, sourcing, etc.), to ... Support protocol development and product evaluations for design changes + Ensure regulatory compliance of all labeling materials + Facilitate cross-functional… more
- Abbott (Plymouth, MN)
- …device and management solutions for the treatment of structural heart disease. The ** Labeling Project Manager ** will be responsible for meeting business needs by ... Experience working in medical device industry with focuses on regulatory compliance, quality systems, labeling , or UDI...with focuses on regulatory compliance, quality systems, labeling , or UDI preferred. + Experience working with ERP… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …the technical aspects of the CGMP's as they relate to product packaging and labeling . Applies this knowledge to day-to-day packaging and labeling activities that ... Supervises union staff in all aspects of packaging and labeling of clinical supplies. + Print clinical labels utilizing...is required. + Strong working knowledge of cGMP's and regulatory (ie, FDA, EU, OSHA, etc.) requirements and their… more
- PCI Pharma Services (Bedford, NH)
- …across our global network to pioneer and shape the future of PCI. The Manager , Visual Inspection, Packaging, and Labeling reports directly to the Director of ... and packaging technicians, ensuring timely product inspection, documentation, bulk packing, labeling , and shipping of sterile clinical and commercial products in… more
- Danaher Corporation (Fargo, ND)
- … Manager , Operational QA, responsible for Developing and implementing labeling processes and procedures and collaborating with cross-functional teams, including ... Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align with regulatory requirements and company branding. This is a remote… more
- Gilead Sciences, Inc. (La Verne, CA)
- …knowledgeable **Senior Manager , Project Management New Product Line Manufacturing - Labeling ** , to lead New Product Introduction (NPI) efforts for the La Verne ... product transfer team can deliver products to meet compliance with regulatory requirements, Current Good Manufacturing Practices (cGMPs), Good Laboratory Practices… more
- System One (Lakewood, CO)
- Title: Senior Content Developer-Product Labeling Instructions Location: Remote Schedule: M-F 8:00 AM-5:00 PM Pay: $79,200-$99,000 - Target Bonus on Base: 7%, ... of Content Developer who will assist in creating comprehensive instructional labeling for cutting-edge medical devices for clinical and commercial products.… more
- Takeda Pharmaceuticals (Boston, MA)
- …worldwide. Join us as Executive Assistant - GRA Marketed Products Development, Global Labeling and Advertising & Promotion team. You will provide support in two ... communication received by regular mail and other administrative support for the manager and leadership team in accordance with Company policies and procedures. 2)… more
- Olympus Corporation of the Americas (Westborough, MA)
- …ancillary labeling -related matters. Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling materials. Responsible ... about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market… 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 ... global development projects and provide regulatory strategy for assigned projects that leads to a...project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions… more
- Rise Baking Company (York, PA)
- …compliance guides, inspection reports, journals, meetings, etc. + Assist the Senior Regulatory Compliance Manager with sustainability customer requests such as ... palm oil and cocoa surveys + Assist Senior Regulatory Compliance Manager with sustainability directives involving regulatory initiatives + Support food… more
- Abbott (Sylmar, CA)
- …device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine...appropriate); + Medical writing + Advertising and promotion + Labeling + Restricted substances reporting as required(eg REACH) +… more
- Hologic (Marlborough, MA)
- Manager , Regulatory Affairs (IVD On-Market/Sustaining) San Diego, CA, United States Marlborough, MA, United States We are hiring in our Diagnostics Regulatory ... Diego or Marlborough campus, and are looking for a Regulatory Affairs Manager , responsible for on-market ...agencies to obtain timely approval. + Provide recommendations on labeling , manufacturing, and analytical and clinical study plans for… more
- Abbott (Santa Clara, CA)
- …in Santa Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within **Abbott ... submissions to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...laws + Principles and requirements of promotion, advertising and labeling + Interpret and apply regulatory requirements.… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at ... way people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC** position will work closely with in-country… 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 ... The Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge of US… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more