Regulatory Affairs Specialist II / Regulatory Affairs Specialist III
Job description
CardioFocus is seeking a RA Specialist that is reaching for the next career level, able to deliver across multiple lanes inside and outside the organization and has the diversity to deliver in a start-up environment.
The Regulatory Affairs Specialist develops content and format for global regulatory submissions with a focus on 510(k)s, PMAs, IDEs, and related supplements and amendments. Executes regulatory strategy for new and currently marketed product approval and supports negotiations with regulatory authorities regarding company filings involving appropriate methods including the Q-Sub process. Serves as regulatory affairs representative on assigned teams to provide guidance on regulatory requirements and submissions resulting in product approvals. Reviews changes to products, processes, and promotional materials to determine regulatory requirements and manages ongoing reports and registrations.
Minimum Qualifications
Requires at a minimum a BS in a science or engineering discipline with 2 or more years of medical device regulatory affairs; or an equivalent combination of education and experience.
Experience with:
EU MDR 2017/745
US Class II 510(k) experience
US Class III medical devices with cardiac electrophysiology devices a plus.
Involvement in international registrations a plus.
SKILLS AND ABILITIES REQUIRED
MUST BE SKILLED in MS Office Suite and Adobe Pro.
Demonstrated leadership and career abilities and the ability to translate regulatory requirements into clear direction for the company.
Must collect and organize diverse information to develop regulatory strategies, guide the organization, and anticipate regulatory needs and fulfill them proactively.
Must support regulatory submission activities for company partners worldwide.
Must prioritize and plan work activities, use time efficiently, plan for additional resources, set goals and objectives, organize or schedule other people and their tasks, and develop realistic action plans.
Must write clearly and informatively; edit work for spelling and grammar; vary writing style to meet needs; present numerical data effectively; be able to read and interpret written information.
Must have a basic technical aptitude to assist in processing complex technical information and clinical and test data and translate complex information into clear, concise regulatory submissions.
Please submit your resume and cover letter to: careers@cardiofocus.com