- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve ... regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to help ensure ...promotional and disease state materials. * May present to senior management, and present regulatory topics to… more
- ConvaTec (Lexington, MA)
- …Convatec, please visit http://www.convatecgroup.com **Job Summary:** In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible ... Tissue Technologies division's global regulatory strategies and processes. The Senior Regulatory Affairs Specialist will drive compliance, mentor colleagues,… more
- Medtronic (Boston, MA)
- …guidance you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team ... to market. It involves creating, managing and executing global regulatory strategies for new product development as... staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- Amgen (Cambridge, MA)
- …It's time for a career you can be proud of. ** Senior Manager , Systems Engineering - Combination Product Development** **Live** **What you will do** ... vital role you will be the Senior Manager , Systems Engineering (SMSE) in the Combination Product...Demonstrated product design and development success through product launch in major global regulatory regions.… more
- J&J Family of Companies (Boston, MA)
- Senior Product Security Manager - 2406179674W **Description** Johnson & Johnson's MedTech Product Security team is recruiting for an experienced ... Product Security Senior Manager to be based at any...SOC2, FedRAMP) + Familiarity with FDA and/or other global regulatory cybersecurity guidance requirements and submission process + Experience… more
- Wayfair (Boston, MA)
- Who We Are Wayfair seeks a visionary and dynamic Senior Product Manager to lead our data privacy and digital signals integration efforts. This pivotal role ... between user privacy and actionable insights is crucial for competitive advantage. As a Senior Product Manager , you will orchestrate the roadmap for ethical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …purpose and our core values by staying **True to Life.** **Job Description** As a Senior Global Product Manager , Digital Unit for our Healthcare Product ... management, which could include roles such as a product manager , product owner, software...to 0-1 product development in the healthcare product segment + Regulatory and Compliance Experience:… more
- Olympus Corporation of the Americas (Westborough, MA)
- …purpose and our core values by staying **True to Life.** **Job Description** As a Global Product Manager of Digital Unit, you have a unique opportunity to make a ... management, which could include roles such as a product manager , product owner, software...of healthcare coding systems (eg, ICD-10, CPT, SNOMED CT), regulatory compliance, and the healthcare ecosystem. + Experience in… more
- Philips (Cambridge, MA)
- ** Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... RA function to management, including the development of global regulatory strategy in the area of regulatory ...guidance on global compliance, such as CE marking and product registrations, clinical evaluations in accordance with EU MDR,… more
- Point32Health (Canton, MA)
- …ancillary providers and other providers as required. The Senior Contract Manager is responsible for the financial, regulatory , and legal terms negotiated ... we are at Point32Health, click here (https://youtu.be/S5I\_HgoecJQ) . **Job Summary** The Senior Contract Manager will support all Lines of Business, including… more
- J&J Family of Companies (Boston, MA)
- …Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior Local Trial Manager (Sr. LTM) actively contributes to process ... Senior Local Trial Manager - Immunology...to participate in trial. * Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other… more
- Medtronic (Mansfield, MA)
- Senior Clinical Research Business Process Improvement Manager In this exciting role as Senior Clinical Research Manager in the Surgical Operating Unit, ... the Surgical Operational Excellence sub-function. In this role, the Senior Clinical Research Manager will be in...for the conduct of clinical studies and for the regulatory affairs function as it applies to product… more
- Candela Corporation (Marlborough, MA)
- ** Senior Program Manager ** Requisition Number **2756**...the product family in conjunction with the product manager within each of the GBU's ... of. These programs are supported by Candela's global clinical, regulatory , and quality teams and are managed through our...cycle, making project execution decisions in conjunction with the product manager and functional management. . Leads… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and our core values by staying **True to Life.** **Job Description** The Manager , Senior Global MDR Submission is responsible for managing Market Quality- ... COE MDR team for the regulatory assessment and submission of Medical Device Reports to...review, processing and submission of potential adverse events. The Manager , Sr. Global MDR Submission works closely with the… more
- Sanofi Group (Cambridge, MA)
- …treatment to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty ... (PRIL) is designed to oversee temporary authorization and importation of a product allowing patients with medical needs earlier access to treatment. Humanitarian… more
- Citizens (Westwood, MA)
- Description The Senior Manager of Non-Financial Risk Management Oversight is responsible for the independent oversight, review and effective challenge and risk ... degree Required + Certifications Preferred: Certified Internal Auditor, Certified Regulatory Compliance Manager , Accredited Payments Risk Professional, Certified… more
- Gilead Sciences, Inc. (Boston, MA)
- …performance, development, and career interests. Position will be filled as a Senior Manager or Associate Director, based on candidate experience. ... and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information… more
- Point32Health (Canton, MA)
- …we are at Point32Health, click here (https://youtu.be/S5I\_HgoecJQ) . **Job Summary** The Senior Compliance Program Manager will be responsible for development, ... involve multiple business areas, multiple lines of business, and potentially IT. The Senior Compliance Program Manager will be responsible for collaborating with… more
- Generac Power Systems (Bedford, MA)
- ** Senior Manager Mechanical Engineering - Clean Energy** **Company** Generac Power Systems **Name** Senior Manager Mechanical Engineering - Clean Energy ... ME; Bedford, MA; or Vancouver, BC;. Level of role ( Manager or Senior Manager ) will...battery packs or ESS + Experience with UL 9540A regulatory requirements and testing + Experience in rapid prototyping… more
- Fresenius Medical Center (Waltham, MA)
- …company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, ... regulatory assessment and support. + Evaluates and assesses regulatory impact of proposed product changes. +...selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of… more