Jobs
>
Boston

    Quality Regulatory Manager - Boston, United States - Gabriele & Company

    Default job background
    Upper Management / Consulting
    Description

    Job Title: Quality and Regulatory Project Manager

    Gabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose products are used in nearly half of all hospitals in the US. This world leader in their market niche is seeking an exceptional Quality and Regulatory Project Manager to drive new product line initiatives.

    Reporting to the VP, you will spearhead the management of new product line(s). In this pivotal role, you will collaborate cross-functionally to ensure products seamlessly align with technical, regulatory, clinical, and market standards.

    Salary Range: $120,000 - $150,000 per year, commensurate with experience, along with a generous benefits package.

    Key Responsibilities:

    • Create and manage comprehensive product/project databases
    • Develop and execute strategic product line release plan(s)
    • Work closely with Regulatory lead/Quality team, keeping stakeholders updated
    • Liaise across departments for regulatory documentation (domestic & international)
    • Manage clinical/non-clinical stakeholders for product release readiness
    • Maintain, improve and update all relevant regulatory documentation/best practices
    • Participate in CAPA Review Board, recommending corrective actions
    • Assist with regulatory information management system, QMSR processes, new eQMS

    Requirements:

    Bachelor's degree

    • 7+ years of Quality/Regulatory Affairs experience in Medical Device industry
    • Regulatory Affairs knowledge
    • Quality Management system knowledge
    • 510K submissions
    • Clinical submissions and trials
    • MDR (Medical Device Rugulation/Reporting)
    • ISO
    • EU requirements
    • MDSAP (Medical Device Single Audit Program)
    • Auditing experience

    Please apply or reach out if interested in this Quality and Regulatory Project Manager opportunity with a global medical device leader



  • Velocity Enterprises Tremont, United States

    Head of Regulatory Affairs · Your Responsibilities · Development and implementation of the regulatory affairs strategy for new and existing products in Germany · Leadership of the regulatory affairs team · Negotiations and interactions with health authorities for pharmaceuticals, ...


  • Exergen Corporation Watertown, United States

    _**Exergen Corporation**_ _is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever pre ...


  • Insmed Incorporated Bridgewater, United States

    Company Description: · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...


  • Atea Pharmaceuticals Inc. Boston, MA, United States

    The Director Regulatory CMC will be responsible for developing and delivering innovative regulatory CMC strategies for product development and approval. With limited guidance from the EVP Regulatory Affairs & Quality Assurance, the incumbent acts as the regulatory CMC expert for ...


  • Dennis Partners Boston, MA, United States Freelance

    Our client is developing precision delivery platforms for the treatment of neurological and oncological disorders. They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Reporting int ...


  • PSG Global Solutions Cambridge, United States

    We're looking for a · Manager of Regulatory Affairs , working in · Biotechnology/Medical Devices · industry in · Cambridge, Massachusetts, United States . · Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, ...


  • Katalyst HealthCares & Life Sciences Cambridge, United States

    Responsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements ...


  • PSG Global Solutions Careers Cambridge, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Manager of Regulatory Affairs, working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States. · Works ...


  • Northern Trust Boston, United States

    About Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world's most successful ...


  • Northern Trust Boston, United States Full time

    About Northern Trust: · Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. · Northern Trust is proud to provide innovative financial services and guidance to the world's most suc ...


  • Takeda Boston, United States Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...


  • The Fountain Group Cambridge, United States

    The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows: · Job Description: · Pay: /hr on W2. · 6-month assignment t ...


  • Biogen Cambridge, United States

    Job Description · Manager, Global Regulatory Affairs · About This Role · The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a membe ...


  • Takeda Development Center Americas, Inc Cambridge, United States

    Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...


  • Innova Solutions Cambridge, United States

    Innova Solutions is immediately hiring for a Regulatory Affairs Manager III · Position: Type: Full Time, Contract · Duration: 06 Months (Possibility to extend) · Location: 100% Remote or hybrid (Cambridge, MA or RTP) · Note: 100% Remote or hybrid (Cambridge, MA or RTP) · Job ...


  • Relay Therapeutics Cambridge, United States

    The Opportunity: · We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to help define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipelin ...


  • Philips Iberica Sau Cambridge, United States

    Job Title Sr. Regulatory Affairs Manager Job Description · Senior Regulatory Affairs Manager (U.S. 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 ...


  • Randstad Somerville, United States

    This is a hybrid role and will require an onsite presence at Assembly Row in Somerville 1x/week. · The Finance & Regulatory Reporting Manager will be part of an interdisciplinary accounting and reporting team responsible for overseeing the monthly journal entries and accounts re ...


  • Philips Cambridge, MA, United States

    Job TitleSr. Manager Regulatory Affairs Job Description · The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease Management Solution products, ensuring and maintaining ...


  • Partners , Inc. Somerville, United States

    : · This is a hybrid role and will require an onsite presence at Assembly Row in Somerville 1x/week. · The Finance & Regulatory Reporting Manager will be part of an interdisciplinary accounting and reporting team responsible for overseeing the monthly journal entries and account ...