Senior Regulatory Affairs Specialist
At Advanced Clinical, we’re excited to share with you a great opportunity as we search for a Senior Regulatory Affairs Specialist to join a growing organization. This customer-focused company with an entrepreneurial spirit, is producing some of the most reliable and technologically medical device products in the world. Located in Aliso Viejo, CA, this Senior Regulatory Affairs Specialist will partner with a hard working and energetic team that goes above and beyond for each other. For more details please email NSwiecicki@advancedclinical.com.
- Developing plans for regulatory submissions, prepares, reviews and files for worldwide regulatory submissions.
- Executing regulatory requirements in Europe, Middle East & Latin America.
- Communicating with regulatory agencies on administrative and routine matters.
- Documenting, consolidating and maintaining oral and written communication with the regulatory agencies/distributors.
- Developing and maintaining regulatory files and records.
- Reviewing change order documents and ascertains impact on current regulatory approvals.
- Assisting in routine audits as requested.
- Minimum five (5) years of medical device industry experience.
- Minimum five (5) years of Regulatory Affairs experience.
- Ability to work independently and manage multiple priorities effectively.
- Excellent written and verbal communication skills required.
- Exceptional interpersonal and communication skills are key.
- Successful experience working independently, effectively and confidently in a team environment.
- Ability to multi-task, project coordination ability and acute attention to detail.
- Must be detail oriented.
- Proven analytical abilities and organization skills.
- Ability to comprehend technical documents and concepts.
- Experience in preparation of U.S. and international regulatory submissions.
- Bachelor’s Degree in Science, Engineering or Medical Technology.