Regulatory Compliance Expert

3 weeks ago


Marlborough, Massachusetts, United States US Fertility, LLC Full time
Job Overview

The Regulatory and Quality Assurance Specialist II plays a vital role in ensuring the company's compliance with regulatory agencies, including FDA, state, local, and AABB. This position requires a high level of expertise in quality systems and regulatory aspects.

Key Responsibilities:
  • Implement, monitor, and maintain the company's Quality System to ensure compliance with regulations.
  • Develop and maintain a document control system to track and manage documents related to quality and regulatory aspects.
  • Analyze and interpret federal and state regulations applicable to the company's products and processes.

Requirements:

  • Bachelor's degree or equivalent combination of training and experience.
  • Excellent communication and interpersonal skills to handle sensitive and confidential situations.
  • Ability to work independently and as part of a multi-disciplinary team.
  • Proficiency in computer software applications, including word processing, spreadsheets, database, and presentation software.

Estimated Salary: $110,000 - $130,000 per year.



  • Marlborough, Massachusetts, United States SARTORIUS AG Full time

    At Sartorius AG, we seek a dedicated Quality Control Lead to drive the success of our initiative in creating innovative solutions.Job OverviewThe successful candidate will oversee quality control activities ensuring the quality and compliance of our emerging therapy services.This includes management of QC microbology testing, environmental monitoring,...


  • Marlborough, Massachusetts, United States RQM+ Full time

    About RQM+RQM+ is a leading MedTech service provider with the world's largest global team of regulatory and quality experts.With 40 years of regulatory expertise, we provide comprehensive clinical trial, lab and reimbursement services - reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital...


  • Marlborough, Massachusetts, United States Pharmavise Corporation Full time

    Job Summary:The Regulatory Compliance Labeling Specialist will be responsible for planning, managing, and directing the creation/revision of product literature and labeling. This individual will work closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures.Responsibilities:Coordinate all product...

  • Compliance Expert

    2 days ago


    Marlborough, Massachusetts, United States GTT, LLC Full time

    Responsibilities and QualificationsThis Junior Compliance Risk Analyst role involves a range of responsibilities, including:Implementing and tracking completions for corporate compliance training, including escalation management.Developing year-over-year analysis and trends of completion rates progress to highlight areas of significant progress and areas of...


  • Marlborough, Massachusetts, United States US Fertility, LLC Full time

    Role SummaryThis is a key role within US Fertility, LLC, responsible for overseeing the implementation and maintenance of the company's Quality System, ensuring compliance with regulatory agencies.Key Accountabilities:Implement, monitor, and maintain the Quality System to ensure compliance with regulations.Develop and implement a document control system to...


  • Marlborough, Massachusetts, United States Boston Scientific Full time

    OverviewBoston Scientific is seeking an experienced professional to lead its IT SOX program, ensuring compliance with regulatory standards and best practices in the medical device industry.Salary Range: $100,700 - $191,300 per yearAbout the Role: As an IT SOX Program Lead, you will be responsible for overseeing the company's IT SOX, internal controls, and...


  • Marlborough, Massachusetts, United States Lifelancer Full time

    We are seeking an exceptional Associate Director of Compliance to join our team at Lifelancer. In this role, you will be responsible for ensuring compliance with all applicable regulatory, legal, and operational rules and procedures.You will lead the documentation of regulatory interactions, assess and communicate regulatory requirements, and ensure that all...


  • Marlborough, Massachusetts, United States Lifelancer Full time

    At Lifelancer, we are seeking a highly skilled Global Regulatory Affairs Professional to join our team. This role will be responsible for ensuring the execution of regional regulatory strategies in line with global registration goals.The ideal candidate will have a strong understanding of FDA regulations and guidelines, as well as experience working in a...


  • Marlborough, Massachusetts, United States BioTalent Full time

    Role OverviewBioTalent is seeking a highly skilled Product Safety and Compliance Specialist to join our team. This role plays a critical part in ensuring the quality and safety of our medical devices.Key ResponsibilitiesQuality Assurance: Oversee the product development lifecycle, including risk management, design verification, and validation, to guarantee...


  • Marlborough, Massachusetts, United States US Fertility, LLC Full time

    Job DescriptionThe Regulatory and Quality Assurance Specialist II is responsible for implementing and maintaining quality systems, document control, and compliance with federal and state regulations.This includes:Implementing, monitoring, and improving the company's Quality SystemEnsuring appropriate licensure is held and maintained by the...


  • Marlborough, Massachusetts, United States Allegro MicroSystems Full time

    Allegro MicroSystems is seeking an experienced Trade Compliance Lead to join our team. The successful candidate will be responsible for leading and managing Allegro's trade compliance across the supply chain operations.The Trade Compliance Lead will own and drive the strategic Trade Compliance for Allegro, overseeing multiple programs and processes that...


  • Marlborough, Massachusetts, United States Lifelancer Full time

    Quality Assurance Role SummaryThis Senior Manager position is responsible for leading the Quality Control team and ensuring compliance with regulatory guidelines. The ideal candidate will have a strong background in quality assurance and excellent leadership skills.About the Role:Lead and manage the Quality Control team to ensure compliance with...


  • Marlborough, Massachusetts, United States Boston Scientific Full time

    Boston Scientific OverviewWe stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.As a leader in medical science for over 40 years, we are committed to...


  • Marlborough, Massachusetts, United States RQM+ Full time

    Overview:RQM+ provides comprehensive regulatory and quality services to the MedTech industry. Our expertise spans 40 years, and we have worked with numerous top medical device manufacturers and IVD companies. As a Regulatory Labeling Project Manager, you will play a critical role in ensuring compliance and quality in our clients' labeling processes.Key...

  • EHS Professional

    5 days ago


    Marlborough, Massachusetts, United States MyHR Rescue Full time

    **About this Opportunity**We are seeking a motivated professional to lead site environmental compliance, environmental improvement programs, and be a key member of the Site Environmental, Health, and Safety (EH&S) Team.**Responsibilities:**Serve as the technical expert on matters relating to the site's air pollution control, water and waste infrastructure,...


  • Marlborough, Massachusetts, United States Collins Aerospace Full time

    Navigation Systems ExpertWe are seeking a highly experienced Navigation Systems Expert to join our team at Collins Aerospace. In this role, you will be responsible for the design, development, and integration of navigation systems for our aircraft. You will work closely with cross-functional teams to ensure that our navigation systems meet the highest...

  • Environmental Expert

    3 weeks ago


    Marlborough, Massachusetts, United States KOMAN Government Solutions, LLC Full time

    Job OverviewKOMAN Government Solutions, LLC is seeking an experienced Environmental Expert to support our Northeastern U.S. operations. The ideal candidate will lead field components of environmental investigation and remediation projects for federal customers.Responsibilities:Leads field investigations and remediation projects in New England and the...

  • Electrical Engineer

    5 days ago


    Marlborough, Massachusetts, United States Rimkus Consulting Group, Inc Full time

    Join a dynamic team of experts at Rimkus Consulting Group, Inc. and unlock your potential for growth and success in the field of electrical engineering.Rimkus is a worldwide leader in Engineering and Technical Consulting, providing forensic consulting services requiring electrical engineering expertise to insurance, legal, industrial, and other clients.Job...


  • Marlborough, Massachusetts, United States Rimkus Consulting Group, Inc Full time

    Rimkus Consulting Group, Inc is a leading global engineering and technical consulting firm dedicated to delivering exceptional services to our clients. Our team of experts specializes in various fields, including building envelope, engineering, forensic consulting, dispute resolution, construction management, and environmental solutions.About the PositionWe...


  • Marlborough, Massachusetts, United States Bouvier Pharmacy Full time

    Job DescriptionWe are seeking a highly skilled Per Diem Pharmacist to join our team at Bouvier Pharmacy & Home Medical Solutions. As a key member of our pharmacy team, you will be responsible for leading and directing pharmacy staff, overseeing all aspects of the pharmacy, and providing excellent patient care.Responsibilities:Lead and direct pharmacy staff,...