Address
Form of work- This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
- Assist the strategy implementation and operations for Regulatory Affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Update and develop procedures for the Regulatory Affairs in supporting changes in the regulatory landscape, including EU MDR.
- Identify opportunity for regulatory affair processes and drive changes to completion.
- Perform assigned regulatory activities including submissions/responses to country authorities.
- Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.
- Assist in strategy implementation and operations for Regulatory Affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.
- Assist in maintaining Regulatory records and files.
- Review product changes as assigned and assess required EU MDR submissions/notifications.
Requirements
- Have working knowledge in EU MDR.
- Have working knowledge in Regulatory Change Assessment.
- Have working knowledge in US and EU medical device submissions.
- Have experience supporting internal and external inspections.
- Work cross-functionally and in a matrixed environment.
- Have experience with continuous improvement activities.
- BA Degree Required.
- 3-5 years experiences in Medical Device Regulatory Affairs.
- Strong oral communication and interpersonal skills.
- Proficient in technical writing.
- Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.
- MS Office Suite including an Intermediate level with Excel using Pivot Tables, Creating Trackers in Excel and Monitoring these/Conditional Formatting.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
