Regulatory Affairs Specialist
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
Pre-Requisites/ Job Experience
- Bachelor’s degree in a scientific discipline or equivalent is required
- Experience in Regulatory Affairs with Class II/III devices strongly preferred.