Regulatory Affairs Professional
Job Description
The company is seeking a highly skilled Regulatory Affairs Specialist to join their team. This individual will work closely with cross-functional teams to obtain regulatory approvals and clearances for new medical devices.
Key Responsibilities
* Support the VP Quality and Regulatory Affairs by executing regulatory activities and developing strategies to support business needs.
* Develop high-quality regulatory submissions to ensure timely product clearance and approval.
* Collaborate with development teams to ensure data creation using best scientific principles and submission goals are met.
* Develop and manage product design and technical documentation in compliance with regulations and standards.
* Assure compliance with applicable laws and regulations related to obtaining product approval and maintaining marketing rights.
* Monitor emerging legislation and contribute to ensuring company-level awareness and compliance.
Requirements
* A Bachelor's or Master's degree in a scientific or engineering discipline.
* At least 7 years' experience in Quality Assurance or Regulatory Affairs for medical device companies, with a track record of success with IDE, FDA 510(k), and PMA submissions.
* Strong experience preparing and reviewing regulatory submissions to achieve timely approval.
* Collaborative team player with solid knowledge of the medical device design and development process.
* Excellent written, interpersonal communication, and presentation skills.
* High level of organization with the ability to manage multiple projects.
* Able to apply excellent analytical and computer skills in conducting research, analyzing data, and writing technical documents.
For Further Information
Please contact James Cassidy or call 086 0204322 in confidence.