- Syner-G BioPharma Group (Boston, MA)
- …industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital ... We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients… more
- Repligen (Waltham, MA)
- …shared success-where every voice matters and every contribution drives progress. Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager ... owners to ensure timely testing, certifications, and issue resolution.Train and support control owners to maintain accurate, compliant SOX documentation.Evaluate the… more
- Aequor (Northborough, MA)
- …process of performing these functions, Packaging interacts with and receives support from the Quality Assurance, Materials Management, Facilities Engineering, ... Validation, Metrology and Manufacturing Technical Support groups. In addition, Packaging interacts with outside contractors, vendors, internal auditors and… more
- Danaher Corporation (Marlborough, MA)
- …the Danaher Business System which makes everything possible. The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the ... Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change… more
- Danaher Corporation (Marlborough, MA)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior manager , Customer Regulatory Support is ... the Department Director for Regulatory Care and is part of the Customer Regulatory Support team within QARA located in Marlborough, MA or Uppsala, Sweden and… more
- Danaher Corporation (Marlborough, MA)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Manager , Customer Regulatory Support is ... responses within the customer interaction management system (SFDC) for Regulatory Support related cases. This position reports...+ Minimum 2 years' experience in product management, product support , or quality in a life sciences… more
- Brockton Hospital (Brockton, MA)
- …our patients. Position Summary: Under the general supervision of the Vice President of Quality Resources, the Manager of Regulatory Compliance is responsible ... support and consultative services to meet accreditation and regulatory standards. The Manager develops and monitors... regulatory standards and accreditation requirements related to quality and safety and support teams and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Act, Cybersecurity regulations, and relevant consumer protection laws). + Oversee and support regulatory submissions and compliance filings where applicable (eg, ... Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... EU SmPC. You will also be responsible for providing support to the development and implementation of labeling content...and requirements. + Basic knowledge of scientific principles and regulatory / quality systems relevant to drug development. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …regulatory due diligence in vendor and technology selection. + Oversee and support regulatory submissions and compliance filings where applicable (eg, AI risk ... classification documentation, cybersecurity certifications, and voluntary compliance frameworks). + Support responses to inquiries from regulatory authorities,… more
- Oracle (Boston, MA)
- …innovators worldwide. **The Role** We are seeking a **Senior Principal Product Manager ** who deeply understands the ** regulatory , clinical, and financial ... you will lead the strategy, design, and delivery of regulatory and clinical data products that support ...+ Ensure that our platform helps customers meet evolving regulatory , financial, and quality measurement requirements. This… more
- ThermoFisher Scientific (Waltham, MA)
- …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a...information systems, with our strategic objectives. You will manage regulatory professionals, providing guidance and support to… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of… more
- Dentsply Sirona (Waltham, MA)
- …submissions, FDA 510(k) submissions and EU technical files submissions. + Provides regulatory guidance and support to cross-functional teams throughout the ... portfolio of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and deliver better… more
- Santander US (Boston, MA)
- Program/Project Manager - I-Banking Regulatory , Vice President Country: United States of America **Your Journey Starts Here:** Santander is a global leader and ... skills providing solutions for CIB US with a focus on regulatory and non-financial risk related initiatives. Qualified candidate must have extensive… more
- Grant Thornton (Boston, MA)
- As a Regulatory & Practice Review Seasonal Senior Manager you'll support audit teams for regulatory inspection with all with the resources, environment, ... and support to help you excel. Your day-to-day may include:...include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's… more
- Medtronic (Boston, MA)
- …following and other duties may be assigned. + Provide strategic and technical regulatory guidance to support design and manufacturing sustaining covering both ... quality , clinical, marketing, and other departments to fulfill regulatory responsibilities. + Review and approve promotional and advertising materials for… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Participate in teams for sustaining products to provide input on global regulatory requirements. + Support regulatory submissions, filings, and responses ... of a high-growth, innovative team, the RA Specialist II will provide regulatory guidance, prepare and maintain documentation, and support submissions related… more
- Medtronic (Newton, MA)
- …outcomes to achieve required levels of product reliability. + Provide software quality support for post-market activities and analysis, including issue ... to engineer the extraordinary. Join Medtronic as a **Software Reliability Engineering Program Manager - Quality Core Team Member** and be at the forefront… more
- Integra LifeSciences (Braintree, MA)
- …in ensuring ongoing regulatory compliance across site operations. The Associate Manager will also support external audit readiness and execution, including ... completion of compliance obligations and remediation commitments. + Lead or support quality improvement initiatives and cross-functional compliance projects as… more
