Principal Regulatory Affairs Specialist

2 months ago

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 regulatory submissions in the US, EU and outside of US (OUS) geographies.


Responsibilities

  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
  • Develops global regulatory strategies for new and modified products.
  • Prepares and submits PMA and IDE Submissions and Supplements. Works with international affiliates to compile and submit international product registrations and licensing applications.
  • Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
  • Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
  • Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, and governing procedures and processes.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Reviews protocols and reports to support regulatory submissions.
  • Creates, reviews and approves engineering change requests.
  • Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.


Required Qualifications

  • Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
  • Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
  • 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).

Preferred Qualifications

  • 5-7 years’ experience in a regulated industry with a minimum of 3 of those years directly related to Class III Medical Devices.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Ability to work effectively on project teams.
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Strong written, verbal, presentation, and organizational skills.
  • Strong analytical and problem-solving skills.
  • Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
  • Experience with medical device software requirements and software regulations.
  • Ability to identify risk areas and escalate issues as appropriate.

  • Principal Regulatory Affairs Specialist

    4 weeks ago

    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...

  • Principal Regulatory Affairs Specialist

    4 weeks ago

    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...

  • Principal Regulatory Affairs Specialist

    1 month ago

    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...

  • Principal Regulatory Affairs Specialist

    1 month ago

    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...

  • Principal Regulatory Affairs Specialist

    1 month ago

    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...

  • Principal Regulatory Affairs Specialist

    4 weeks ago

    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...

  • Principal Regulatory Affairs Specialist

    2 months ago

    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...

  • Principal Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Principal Regulatory Affairs Specialist

    2 months ago

    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...

  • Regulatory Affairs Specialist

    3 weeks ago

    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...

  • Regulatory Affairs Specialist

    4 weeks ago

    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...

  • Regulatory Affairs Specialist

    1 month ago

    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...

  • Regulatory Affairs Specialist

    4 weeks ago

    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...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    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...

  • Product Stewardship and Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Product Stewardship and Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Product Stewardship and Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Product Stewardship and Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Labeling Manager

    1 week ago

    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...

  • Regulatory Affairs Expert

    1 week ago

    Atlanta, Georgia, United States Barrington James Full time

    Regulatory Affairs Expert - Medical DeviceBarrington James is seeking a highly skilled Regulatory Affairs Expert to join their team. As a key member of the Regulatory team, you will be responsible for developing and executing regulatory strategies for unique medical devices.Key Responsibilities:Develop and execute regulatory strategies for medical...