Current jobs related to Senior Regulatory Affairs Specialist - Bedford - Werfen

  • Senior Director Regulatory Affairs

    7 days ago

    Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Job Title: Senior Director, Regulatory AffairsLantheus Medical Imaging Inc is seeking an experienced Senior Director to lead our Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to drive business growth.Key Responsibilities:Lead and manage a...

  • Regulatory Affairs Specialist

    2 weeks ago

    New Bedford, Massachusetts, United States Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a deep understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO 13485 and other international standards.Key...

  • Regulatory Affairs Specialist

    1 week ago

    New Bedford, Massachusetts, United States Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is responsible for ensuring compliance with regulatory requirements for SaMD products in domestic and international markets. This role requires a deep understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO 13485 and other international standards.Key ResponsibilitiesDevelop and...

  • Senior Vice President, Medical Affairs Director

    3 weeks ago

    Bedford, Massachusetts, United States Lantheus Full time

    About the RoleLantheus is a leading healthcare company that has been at the forefront of medical imaging and diagnostics for over 60 years. We are committed to enhancing patient care and empowering clinicians to find, fight, and follow disease.We are seeking a highly experienced and skilled Senior Vice President, Medical Affairs to lead our Medical Affairs...

  • Manager of Regulatory Affairs and Data Entry

    2 weeks ago

    Bedford, Texas, United States Carter BloodCare Full time

    Job SummaryCarter BloodCare is seeking a highly skilled and experienced Manager of Regulatory Affairs and Data Entry to join our team. As a key member of our organization, you will be responsible for overseeing the management and supervision of assigned staff, ensuring the accuracy and compliance of blood collection data, and maintaining the highest...

  • Associate Director, Regulatory Affairs, CMC

    2 months ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...

  • Senior Vice President, Medical Affairs

    2 months ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...

  • Vice President, Medical Affairs Director

    3 weeks ago

    Bedford, Massachusetts, United States Lantheus Full time

    Job SummaryWe are seeking a highly experienced and skilled Vice President, Medical Affairs to lead our Medical Affairs function and contribute to the success of our organization.Key ResponsibilitiesLead and manage the Medical Affairs function, allocating and directing internal resources and effectively utilizing outsourcing to achieve project and business...

  • Vice President, Medical Affairs

    4 weeks ago

    Bedford, United States Progenics Pharmaceutical Inc Full time

    Job DescriptionJob DescriptionJob Title: Vice President Medical Affairs ____________________________________________________________________________________ Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and...

  • Certified Nursing Assistant

    2 weeks ago

    New Bedford, Massachusetts, United States Senior Living Recruiting Specialist Full time

    Job SummaryWe are seeking a compassionate and skilled Certified Nursing Assistant (CNA) to join our team at a senior living community. As a CNA, you will play a vital role in providing high-quality care to our residents, ensuring their physical, emotional, and social needs are met.ResponsibilitiesProvide personal care to residents, including bathing,...

  • Regulatory Affairs Manager

    3 weeks ago

    New Bedford, Massachusetts, United States Lantheus Full time

    Lantheus is a leading healthcare company that has been at the forefront of medical imaging for over 60 years. Our innovative diagnostics, targeted therapeutics, and artificial intelligence solutions empower clinicians to find, fight, and follow disease.As a key member of our team, you will play a critical role in ensuring the development, maintenance, and...

  • Regulatory Affairs Manager

    2 weeks ago

    New Bedford, Massachusetts, United States Lantheus Full time

    Lantheus is a pioneering company in the field of medical imaging, with a rich history of innovation and a commitment to enhancing patient care.As a key member of our team, you will play a critical role in ensuring the development, maintenance, and implementation of global product labeling components, while applying your knowledge of global regulations to...

  • Vice President, Medical Affairs Director

    3 weeks ago

    Bedford, Massachusetts, United States Progenics Pharmaceutical Inc Full time

    Job DescriptionJob Title: Vice President, Medical AffairsJob Summary:We are seeking a highly experienced and skilled Vice President, Medical Affairs to lead our Medical Affairs function. This individual will be responsible for developing and executing strategies to support the commercialization of our products, as well as providing medical and scientific...

  • Manager, Regulatory Affairs, Labeling

    3 months ago

    Bedford, United States Lantheus Full time

    Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.  Lantheus is an entrepreneurial, agile, growing organization that provides...

  • Manager, Regulatory Affairs, Labeling

    4 months ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...

  • Regulatory Compliance Manager I

    1 month ago

    Bedford, Massachusetts, United States Werfen Full time

    Overview:As a Regulatory Compliance Manager I at Werfen, you will play a pivotal role in overseeing the pre-market regulatory activities essential for ensuring adherence to various global standards, including US FDA, Health Canada, and European regulations for in vitro diagnostic devices.Key Responsibilities:Pre-Market Activities:Engage with design teams to...

  • Certified Nursing Assistant

    4 weeks ago

    New Bedford, Massachusetts, United States Senior Living Recruiting Specialist Full time

    Certified Nursing Assistant (CNA) / Home Health Aide (HHA) PositionAre you a dedicated CNA seeking a stable work environment with opportunities for advancement and excellent benefits? This position may be ideal for you. Our organization prioritizes CNAs who are passionate about providing exceptional care to residents and are eager to develop their...

  • Certified Nursing Assistant Position

    4 weeks ago

    New Bedford, Massachusetts, United States Senior Living Recruiting Specialist Full time

    Certified Nursing Assistant (CNA) / Home Health Aide (HHA) RoleAre you a dedicated CNA seeking a stable career with opportunities for advancement and excellent benefits? This position may be the ideal match for you. Our organization prioritizes CNAs who are passionate about providing exceptional care to residents and are eager to grow professionally.Review...

  • Certified Nursing Assistant Position

    4 weeks ago

    New Bedford, Massachusetts, United States Senior Living Recruiting Specialist Full time

    Certified Nursing Assistant (CNA) / Home Health Aide (HHA) PositionAre you a dedicated CNA seeking a stable career with opportunities for advancement and excellent benefits? This position may be the ideal match for you. Our organization prioritizes CNAs who are passionate about providing exceptional care to residents and are eager to grow...

  • Certified Nursing Assistant Position

    4 weeks ago

    New Bedford, Massachusetts, United States Senior Living Recruiting Specialist Full time

    Certified Nursing Assistant (CNA) / Home Health Aide (HHA) PositionAre you a dedicated CNA seeking a stable work environment with opportunities for advancement and excellent benefits? This position may be the ideal match for you. Our organization values CNAs who are passionate about providing care and are eager to grow professionally.Review and assess...

Senior Regulatory Affairs Specialist

4 months ago

Bedford, United States Werfen Full time
Overview

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

Responsible for China NMPA and Japan PMDA registration and renewal activities for IL-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain regulatory compliance.

Responsibilities

Key Accountabilities:

Responsible to participate on design and risk management teams (both Hemostasis and Acute Care) as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements, including:

  • Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input.
  • Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output.
  • Prepare new product registration packages for China NMPA and Japan PMDA.
  • Provide support materials for Milan Regulatory for other country registrations.
  • Assist with product renewal packages to maintain country registrations.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards.
  • Responsible for maintenance of Regulatory Database in SAP.
  • Responsible to review marketing and sign promotional materials for signature by management (as appropriate).
  • Responsible to review and sign labeling and Change Orders (as appropriate).
  • Educate and train IL personnel on international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated.
  • Other assignments related to RA/QA to support Werfen requirements and priorities.

Networking/Key relationships:

To be determined based on department needs. This individual needs to develop relationships working with the domestic and international Quality, Regulatory, R&D, Marketing and Operations teams.

Skills & Capabilities:

  • Effective decision maker
  • Excellent communication skills to facility agreement/coordination between different groups/departments
  • Knowledge in NMPA and PMDA medical device regulations
  • Act as an advisor and educator to Company on NMPA and PMDA regulations and requirements
  • Ability to prioritize and plan work with minimal supervision in a fast-pace environment.
Qualifications

Minimum Knowledge & Experience required for the position

Education: Bachelor's degree in engineering or science, advanced degree

Experience:

  • Minimum of 5-years' experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience
  • Experience in the preparation of technical submission to obtain NMPA and /or PMDA regulatory approval.
    • Demonstrated understanding of NMPA Decree 680 along with its lower-level regulations pertaining to the QMS and other general product registration matters, as well as CFR 21 820/ISO 13485 requirements.
  • Additional skills/knowledge:
    • Effective verbal and written communication in individual and group settings
    • Excellent analytical and strategic thinking skills
    • Strong project management skill
    • Cross-cultural project experience a plus
    • RAC certification is a big plus
    • Language fluency: English and Chinese essential

International Mobility: Required:

  • No

Travel Requirements:

  • Available to travel domestically and internationally as needed.