Principal Regulatory Affairs Specialist

1 month ago


Atlanta, United States EPM Scientific Full time

Title: Principal Regulatory Affairs Specialist

A leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products.

Responsibilities:

  • Act as the regulatory representative on core product development teams and provide input related to FDA and international product registrations and licensing requirements
  • Develop global strategies for new and modified products
  • Prepare and submit PMA and IDE submissions and supplements
  • Compile and submit international product registrations and licensing applications
  • Maintain licensing, registration, and listing information
  • Support the product release process by creating GTS licenses
  • Review and advise on labeling, product claims, and ad promo brochures

Qualifications

  • Minimum 5+ years of experience in Regulatory Affairs with at least 3 years working directly on class III medical devices
  • Must have 510k and PMA submission experience
  • RAC Certification
  • Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
  • Experience with medical device software requirements and software regulations


  • atlanta, United States EPM Scientific Full time

    Title: Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products. Responsibilities:Act as the regulatory representative on core product...


  • Atlanta, United States EPM Scientific Full time

    Title: Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products. Responsibilities:Act as the regulatory representative on core product...


  • Atlanta, United States EPM Scientific Full time

    Job DescriptionJob DescriptionTitle: Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products.Responsibilities:Act as the regulatory...


  • Atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...


  • Atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...


  • Atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...


  • atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...


  • atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...


  • Atlanta, Georgia, United States EPM Scientific Full time

    Job Title: Principal Regulatory Affairs SpecialistWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at EPM Scientific. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and supporting the development of our medical device and diagnostics...


  • Atlanta, Georgia, United States EPM Scientific Full time

    EPM Scientific is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products. Responsibilities: * Act as the regulatory representative on core product development teams and provide input related to FDA and international product...


  • Atlanta, Georgia, United States Accordance Search Group Full time

    Job Title: Principal Regulatory Affairs SpecialistAccordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified...


  • Atlanta, Georgia, United States Accordance Search Group Full time

    Principal Regulatory Affairs SpecialistAccordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in Atlanta, GA.The ideal candidate will have a strong background in regulatory affairs, with experience in developing global regulatory strategies for new and modified Class III devices. They will be responsible...


  • Atlanta, United States Abbott Laboratories Full time

    Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream ofFree medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...


  • Atlanta, Georgia, United States Abbott Full time

    About AbbottAbbott 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.Job DescriptionWe are seeking a highly skilled Senior...


  • Atlanta, Georgia, United States Kemira Full time

    About KemiraKemira is a global leader in sustainable chemistry, driving human progress and quality of life through innovative solutions. With a rich history spanning over 100 years, we've established ourselves as a trusted partner in the water-intensive industries. Our mission is to create chemistry with a purpose, better every day.Job SummaryWe're seeking a...


  • atlanta, United States Kemira Full time

    Kemira is a global leader in sustainable chemistry for water intensive industries. For more than 100 years, our chemistry has advanced human progress and quality of life. We call it chemistry with a purpose, better every day. At Kemira, we foster a collaborative and inclusive work culture that empowers our employees to thrive and make a difference. Learn...


  • Atlanta, United States Kemira Full time

    Kemira is a global leader in sustainable chemistry for water intensive industries. For more than 100 years, our chemistry has advanced human progress and quality of life. We call it chemistry with a purpose, better every day. At Kemira, we foster a collaborative and inclusive work culture that empowers our employees to thrive and make a difference. Learn...


  • Atlanta, United States Kemira Full time

    Kemira is a global leader in sustainable chemistry for water intensive industries. For more than 100 years, our chemistry has advanced human progress and quality of life. We call it chemistry with a purpose, better every day. At Kemira, we foster a collaborative and inclusive work culture that empowers our employees to thrive and make a difference. Learn...


  • Atlanta, Georgia, United States Proclinical Staffing Full time

    Job Title: Manager, Regulatory Affairs LabelingProclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company.Key Responsibilities:Lead the development of new labeling content in collaboration with a cross-functional project team.Manage the creation and maintenance of all US product labeling components using...

  • Product Stewardship

    3 weeks ago


    Atlanta, United States Kemira Full time

    Job DescriptionJob DescriptionKemira is a global leader in sustainable chemistry for water intensive industries. For more than 100 years, our chemistry has advanced human progress and quality of life. We call it chemistry with a purpose, better every day. At Kemira, we foster a collaborative and inclusive work culture that empowers our employees to thrive...