Regulatory Affairs Professional
Job Description:
As a Senior Regulatory Affairs Specialist, you will be responsible for working closely with a cross-functional team to obtain regulatory approvals and clearances needed to support clinical and commercial use of an innovative new therapy. You will develop regulatory strategies to support business needs, execute regulatory activities, and lead preparation, review, and submission of high-quality responses to questions from regulatory agencies.
Key Responsibilities:
* Develop regulatory submissions to ensure timely product clearance/approval
* Collaborate with the development team to ensure that data is created using best scientific principles
* Manage product design and technical documentation in compliance with relevant regulations and standards
* Assure compliance to applicable laws and regulations of all applicable Health Authorities
* Monitor emerging legislation and guidance in appropriate jurisdictions
Required Skills and Qualifications:
* 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
* 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 more information, please contact James Cassidy or call in confidence.