- 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 (Mansfield, 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
- Dairy Farmers of America (Wilbraham, MA)
- …* Partner with the plant manager on identifying key capital projects that support food safety and quality initiatives * Provide training to the plant ... lead a quality department and ensure effective quality execution, continuous improvement, and regulatory compliance....quality program * Escalate non-conformance events to the quality director and plant manager * Oversee… 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
- Hologic (Marlborough, MA)
- Sr Manager , Quality Assurance Newark, DE, United States Marlborough, MA, United States Are you a strategic leader with a passion for driving compliance, ... regulated environment? At Hologic, we are seeking a **Senior Manager , Quality Assurance** to lead the development,...data to drive decision-making and improvements. + Ability to support audits and regulatory inspections as a… more
- Element Materials Technology (Boxborough, MA)
- …for an experienced quality professional to join its team as a ** Quality Manager ** over-seeing the quality systems of Boxborough, Ma; Pittsfield, ... extended, as agreed with operational management and the Division Quality Manager , to service our customer base...and ensure eQMS usage is monitored and maintained to support quality performance + Develop, analyze and… more