Katalyst Healthcares and Life Sciences
Job Location : Alpharetta,GA, USA
Posted on : 2025-08-20T07:13:27Z
Job Description :
Responsibilities:
- This position will develop and implement Regulatory strategies for new product development and significant changes to existing products, to obtain timely regulatory approval globally.
- This individual will author/approve necessary technical documentation for US, Canada, and EU submissions.
- This position will be the Regulatory Affairs leader for assigned product line(s).
- Independently prepare global pre-market Regulatory strategies and evaluates significant changes, including timing, costs, and design requirements for registrations worldwide.
- Provide regulatory input and technical guidance as a Core Team Member on global regulatory requirements to cross-functional development teams.
- ssess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
- Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.
- Prepare and submit all aspects of Class II/Class III medical device applications for US FDA, EU MDD/MDR and/or Canada including writing, compilation, submission, interaction with health authority(s), and continuing maintenance.
- Lead discussions with Regulatory bodies including preparation of agendas, slides, and publication of meeting minutes, to support timely approvals or resolution of issues.
- Remain current on Regulatory Intelligence in accordance with role and projects, including Global Regulations and Standards.
- Support regional import/export and quality matters to facilitate clearance of product through transportation and distribution.
- Conduct change control impact assessments, inclusive of artwork as well as advertisement and promotional literature to determine compliance with regulations and existing registrations.
Requirements:
- Bachelor's degree in a relevant discipline.
- Minimum of 7 years of experience in Regulatory Affairs for medical devices.
- Prepared and submitted all sections of a US FDA 510k, IDE, or PMA, including writing, compilation, submission, and interaction/negotiation with FDA.
- Led negotiations/discussions with FDA, Health Canada, and/or Notified Bodies related to pre-market submissions and/or resolution of post-market concerns or follow-up for medical devices.
- Led the development and implementation of global Regulatory strategy for new products or significant changes to existing products.
- Experience performing review of Advertisement and Promotional materials.
- Demonstrated computer skills, strong written and interpersonal communication skills.