Senior Regulatory Affairs Specialist

3 days ago


Burlington, Massachusetts, United States Joulé Full time
Job Title: Senior Regulatory Affairs Specialist - Animal Tissue

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Joulé. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements related to animal tissue products.

Key Responsibilities:
  • Manage all activities and tasks related to animal tissue for our products.
  • Respond to regulatory authorities on questions related to animal tissue.
  • Perform annual literature reviews for compliance with animal tissue regulations and guidance.
  • Perform audits of animal tissue suppliers.
Requirements:
  • Bachelor's degree from a four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary.
  • At least 3 years of experience working with animal tissue products.
  • Familiarity with ISO 22442 requirements and its application in medical devices.
  • Ability to read, analyze, and interpret technical procedures and regulations.
  • Ability to understand scientific and technical aspects of medical devices.
  • Able to travel to animal tissue suppliers.
What We Offer:
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


  • Burlington, Massachusetts, United States Joulé Full time

    Job Title: Senior Regulatory Affairs Specialist - Animal TissueJob Summary:We are seeking a highly skilled Senior Regulatory Affairs Specialist - Animal Tissue to join our team at Joulé. As a key member of our Regulatory Affairs department, you will be responsible for managing all activities and tasks related to animal tissue for our products.Key...


  • Burlington, Massachusetts, United States PharmaEssentia U.S.A. Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Contract Specialist to join our team at PharmaEssentia U.S.A. as a key member of our legal department. The successful candidate will be responsible for reviewing and negotiating a wide range of contracts, managing our contracting processes, and overseeing our contracting system.Key...

  • Caregiver Lead

    4 weeks ago


    Burlington, Massachusetts, United States Sunrise Senior Living Full time

    Job SummaryWe are seeking a highly skilled and compassionate Caregiver Lead to join our team at Sunrise Senior Living. As a key member of our care team, you will be responsible for providing exceptional care and support to our residents, while also leading and mentoring our care staff.Key ResponsibilitiesProvide supervisory support to care staff, ensuring...


  • Burlington, Massachusetts, United States Le Maitre Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Corporate Counsel to join our team at LeMaitre Vascular. The successful candidate will be responsible for overseeing all legal and compliance matters of the company, advising management on various departments, identifying risks, and offering advice and alternatives to mitigate risks.Key...


  • Burlington, Massachusetts, United States Glaukos Corporation Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team at Glaukos Corporation. As a key member of our Quality Systems department, you will be responsible for ensuring the implementation and effectiveness of our quality management system.Key ResponsibilitiesOversee and ensure timely completion of...


  • Burlington, Massachusetts, United States PharmaEssentia U.S.A. Full time

    Position OverviewThe Senior Director of Marketing plays a pivotal role within PharmaEssentia, overseeing the creation and execution of initiatives aimed at enhancing brand recognition among healthcare professionals. This leadership position is integral to shaping the marketing strategy and operational plans for both disease states and specific brands.Key...

  • Senior R&D Engineer

    2 weeks ago


    Burlington, Massachusetts, United States BioTalent Full time

    Job Title: Principal ResearchAt BioTalent, we are seeking a highly skilled and experienced Principal Research to lead our R&D efforts in developing innovative medical devices.Key Responsibilities:Develop and process new materials for medical devices, ensuring compliance with regulatory requirements.Manage design control activities, guiding projects from...


  • Burlington, Massachusetts, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories, a global healthcare leader, is seeking a highly skilled Senior Engineer to join our Product Analysis Laboratory team. As a key member of our team, you will play a critical role in ensuring the quality and reliability of our biomedical implant products.Key ResponsibilitiesPerform failure analysis on explanted long-term...


  • Burlington, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Senior Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations, and product quality complaints. This role ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Management System standards. The Senior Associate...


  • Burlington, Massachusetts, United States IPS-Integrated Project Services, LLC Full time

    About the RoleWe are seeking a highly skilled Senior Process Automation Specialist to join our team at IPS-Integrated Project Services, LLC. As a key member of our team, you will provide technical leadership and expertise in process automation, instrumentation, and control systems.Key ResponsibilitiesDevelop and implement process automation solutions for...


  • Burlington, Massachusetts, United States Vericel® Corporation Full time

    Senior Facilities EngineerVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a highly skilled Senior Facilities Engineer to join our team. As a key member of our Operations/Engineering Management group, you will play a critical role in supporting the startup, troubleshooting, commissioning,...


  • Burlington, Massachusetts, United States Abbott Laboratories Full time

    About the RoleAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.We are seeking a highly skilled Senior Product...


  • Burlington, Massachusetts, United States State Street Corporation Full time

    About the RoleWe are seeking a highly skilled Senior Manager of Professional Services Operations to join our team at State Street Corporation. As a key member of our Professional Services Operations team, you will be responsible for driving efficiency, scalability, and risk excellence across our operations.Key ResponsibilitiesSupport the Head of PS...


  • Burlington, Massachusetts, United States State Street Corporation Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Manager of Professional Services Operations to join our team at State Street Corporation. As a key member of our Professional Services Operations team, you will be responsible for driving efficiency, scalability, and risk excellence across our operations.Key ResponsibilitiesSupport the Head...


  • Burlington, Massachusetts, United States PharmaEssentia U.S.A. Full time

    Job OverviewPosition SummaryPharmaEssentia is seeking a seasoned professional to spearhead the Patient Advocacy division within the Medical department. The Director of Patient Advocacy will play a pivotal role in cultivating and nurturing significant relationships with patient advocacy organizations pertinent to PharmaEssentia's therapeutic areas. This role...


  • Burlington, Massachusetts, United States Tufts Medicine Full time

    Job SummaryTufts Medicine is seeking a highly experienced and skilled Senior Vice President of Revenue Cycle Operations to lead our revenue cycle functions. This is a critical role that requires a strong leader with a proven track record of success in managing revenue cycle operations, improving efficiency, and driving revenue growth.Key...


  • Burlington, Massachusetts, United States PharmaEssentia USA, LLC Full time

    About the Role:PharmaEssentia USA, LLC is seeking a highly skilled and experienced Contract Manager to join our team. As a key member of our business operations, you will play a critical role in negotiating and managing contracts with our partners and vendors.Key Responsibilities:Develop and implement contract negotiation strategies to achieve business...

  • Senior IT Director

    3 weeks ago


    Burlington, Massachusetts, United States Fractyl Health, Inc Full time

    Job DescriptionWe are seeking a highly skilled and experienced Senior IT Director to lead and develop strategies around IT operations at Fractyl Health, Inc. As the Senior IT Director, you will be responsible for establishing procedures around IT assets through managing the IT help desk and external vendors. This position will cross-functionally partner with...


  • Burlington, Massachusetts, United States Abbott Laboratories Full time

    About the RoleWe are seeking a highly skilled Senior Electromechanical Engineer to join our team at Abbott Laboratories. As a key member of our Research and Technology group, you will be responsible for designing and developing complex electro-mechanical medical devices and test equipment to support critical aspects of our product development pipeline.Key...


  • Burlington, Massachusetts, United States DeepSearch Staffing Partners Full time

    Senior Customer Support EngineerDeepSearch Staffing Partners is seeking a highly skilled Senior Customer Support Engineer to join our team. As a key member of our support team, you will be responsible for providing advanced technical support to our clients' customers and partners.Key Responsibilities:Provide remote support services for clients, partners, and...