Senior Regulatory Affairs Specialist
Iselin, NJ US
The Senior Regulatory Affairs Specialist evaluates and completes, US and global regulatory projects consistent with the company goals. This individual is responsible for assembling regulatory submissions and technical file/design control dossiers to global regulators. Responsibilities include acting independently as the regulatory representative and working cross-functionally on developmental teams culminating in the preparation of relevant regulatory filings to FDA or other government agencies, product lifecycle management, sustaining regulatory activities and other duties as assigned.
Under general direction and in accordance with all applicable government laws, regulations and Company policies, procedures and guidelines, this position:
- Oversees/supports new regulatory projects consistent with the company goals
- Provides leadership and/or assistance in creating timely regulatory document packages for submissions and registrations of new and mature products
- Manages and maintain regulatory files based on regulatory and post-market requirements
- Pre-market notifications (Class II devices a PLUS)
- Compiles, coordinates, and formats all materials required in submissions, license applications/amendments, technical file documentation and annual reporting
- Participates in cross-functional team meetings to provide regulatory input on design and manufacturing changes.
- Coordinates OUS assessments of changes.
- Support for global registrations
- May have direct interaction with regulatory agencies on defined matters.
- Maintaining regulatory databases and administrative work.
- Reviews and recommends changes for labeling/promotional/advertising materials, manufacturing, marketing and clinical protocol for regulatory compliance to the appropriate regulations, as needed
- Assists in the creation, evaluation, implementation and update of internal regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Maintains awareness, excellent comprehension and appropriate application of relevant regulations including proposed and final rules
- Solves problems in straightforward situations;analyzes possible solutions using technical experience and judgment and precedents
- Requires moderate supervision with latitude for independent judgment
- Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments as needed.
- Design Controls;Interacting and communicating with FDA reviewers
- Participates in the review and approval of Change Orders;generates Change Order packages as needed.
- Change control review;Test protocol + report review;risk management review;creation of labels/UDI
- Uses Business System (FBS) tools in daily work.
- Responsible for communicating business related issues or opportunities to next management level.
- Performs other duties assigned as needed.
Years of Related Experience:
- 5+ years related work experience (Regulatory Affairs) preferably within Medical Device
- Minimum Bachelor's Degree in scientific or related discipline
- Experience with Class II 510(k) experience preferred