The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
As a Regulatory Affairs Specialist at Balt, you will be responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information, support submissions, and review product changes for impact on regulatory filings worldwide.
Prepare international submissions and technical files/design dossiers.
Evaluate changes to manufacturing processes and product design against FDA and international requirements and provide guidance to R&D and manufacturing teams.
Support QA in executing compliance activities involving NCMRs, Process Deviations and Vigilance reporting to regulatory authorities.
Review and approve documents such as change orders, technical documents, test protocols, reports and risk management
Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements
Maintain up-to-date knowledge on domestic regulatory requirements, regulations, standards, and guidance and ensure effective communication to the project teams and management.
In collaboration with the regulatory team, manage interactions with agents, distributors, and consultants to clearly identify regulatory requirements and changes on an ongoing basis
Ensure compliance with company policies, procedures and applicable regulations and standards worldwide.
Support RA director with more complex projects/submissions such as IDE, PMA, 510ks.
Strong interpersonal skills including ability to interact with high degree of diplomacy
Knowledge of US and international medical device regulatory requirement
Experience with Class II/III devices
Experience in Technical File, Design Dossier and/or International registrations
Ability to work effectively in a team environment
Excellent written and oral communication skills
Strong organizational skills
Ability to work independently with minimal supervision in a fast-paced, technically challenging environment where drive is critical to success
Bachelor’s degree in a scientific discipline or equivalent is required
Experience in Regulatory Affairs with Class II/III devices strongly preferred.
Internal Number: 001
About Balt USA
For the past 40 years, Balt’s focus has been to collaborate with the Neurointerventional community to address clinical challenges and improve patient care by providing technical innovations supporting the development of the field, including:
The First Flow Directed Microcatheter
The First Detachable Tip Microcatheter
The First intracranial Braided Stent
The First Flow Diverter
Founded in 1977, Balt’s excellence and DNA originates from its lineage of strong leadership; originating with Balt’s founder, Léopold Plowiecki, then his son Nicolas Plowiecki, and continuing today with the CEO of Balt, Pascal Girin.
As Balt is entering a new and exciting expansion phase combining the well-established Balt family of products with a truly global reach, Balt will continue to design, develop, manufacture and commercialize the most complete suite of neuro innovative products developed through inspired by ongoing collaboration with the Neurointerventional community.