Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations.

Job Description

Roles and Responsibilities

• GEHC ONLY - Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
• Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills.
• Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.
• May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters.
• A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others.

Required Qualifications

• For roles outside of the USA- This role requires basic experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
• For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)).

Desired Characteristics

• 
  Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
   

  Note:

  
  To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

Additional Information