- Dentsply Sirona (Waltham, MA)
- …for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements. This ... regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance… more
- ThermoFisher Scientific (Waltham, MA)
- …is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and ... and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area… more
- Chiesi (Boston, MA)
- …for the better. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi ... to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
- Medtronic (Mansfield, MA)
- …Writing + International medical device regulatory submission/approval experience, to include FDA and EU (specifically EU MDR) + Product Labeling requirements ... product portfolio. This role involves preparing and submitting regulatory documents, such as 510(k) applications and CE technical...or pharmaceutical industry. **Nice to Have** + Knowledge of FDA and EU MDR requirements + Experience of working… more
- Staples (Framingham, MA)
- …in buying, selling, negotiating, operations, design, innovation, finance and more. As the Senior Manager , Product Quality & Safety, you will play a vital role in ... product recall communications. + Working knowledge of federal and state product safety regulations (CPSC, FDA , OSHA, etc.). **What's needed- Basic… more
- Cole-Parmer (Franklin, MA)
- Job Title: Senior Product Manager , Job Title: Senior Product Manager , Global Product Management Reports To: VP, Global Product Marketing, ... internal teams to ensure final product exceeds customer expectations. The Senior Product Manager will be responsible for driving growth by developing and… more
- Hologic (Boston, MA)
- Software Product Manager Marlborough, MA, United States Boston, MA, United States As a Software Product Manager at Hologic, you will drive the vision, ... + Familiarity with radiology clinic IT environments, medical imaging workflows, and regulatory requirements (eg, FDA , HIPAA) + Strong grasp of cloud-based… more
- Philips (Cambridge, MA)
- ** Product Manager , Connectivity Hubs (Cambridge, MA)** As the upstream Product Manager for Medical Device Connectivity Hubs, you will assure the ... and integration solutions. **Your role:** + Own the upstream product management activities for the Connectivity Hubs portfolio lifecycle,...products or medical device integration and working with the FDA and other global regulatory bodies. +… more
- Sodexo (Boston, MA)
- **Role Overview** The **Senior Manager , Product Quality Assurance (PQA)** is a critical member of Sodexo's North America Food Safety team. This role is ... PQA systems are robust, scalable, and aligned with company standards and regulatory requirements. **What You'll Do** **Key Responsibilities:** + Manage PQA programs… more
- Medtronic (Boston, MA)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Product Security Engineer plays a critical role in ensuring the security of Medtronic ... Operating Unit medical device solutions. Reporting to the Director of Product Security, this role supports the integration of advanced cybersecurity measures,… more
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