Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. 
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). 
Review/approval of engineering study protocols/reports and validation study protocols/reports. 
Review and approval of manufacturing changes for Class III implantable medical devices. 
May require an advanced degree and 5-8 years of direct experience in the field. 
Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. 
Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. 
May lead and direct the work of others. 
A wide degree of creativity and latitude is expected. 

Typically reports to a manager or head of a unit/department.
Provide support for the regulatory department to ensure efficient and compliant business processes and environment. 
The individual may execute tasks and exercise influence generally at the middle management level. 
The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide. 

 

Top 5 skills/requirements HM would like to see on a resume - 
• Quick learner and team player 
• Effective written and oral communication skills 
• Critical and Analytical thinking skills. 
• Attention to details 
• Basic Technical knowledge on diagnostics and exposure to Regulatory documentation is preferable. 
• Multitasking , be able to work in fast paced environment to meet dead lines and project management skills is an asset. 

 

Interview preference - video