Quality Lead Specialist - Regulatory Affairs

Job Title

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launches, premarket submissions/registrations, and postmarket compliance, working closely with global healthcare regulatory bodies.

Roles and Responsibilities

• GEHC only Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launches, premarket submissions/registrations, and postmarket compliance, while collaborating with global healthcare regulatory bodies.
• Develops in-depth expertise within the discipline; applies prior experience and acquired knowledge to execute functional policy and strategy.
• Typically operates as an individual contributor with strong interpersonal skills. Communicates with colleagues and the business regarding design and coordination activities. Provides informal guidance to new team members and explains complex information in straightforward scenarios.
• Impacts projects, processes, and procedures within own field. Operates with some autonomy, focusing on execution and the provision of guidance within established functional practices and procedures. Activities require professional judgment and may involve occasional guidance from more senior team members.
• Utilizes technical expertise and judgment to solve problems. Applies analytical thinking and leverages multiple internal resources, including those outside the immediate team, to support decision-making.

Required Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma/GED with at least 6 years of experience in the relevant job family/function).
• At least two years of relevant experience in Regulatory Affairs.

Desired Characteristics

• Strong oral and written communication skills
• Demonstrated ability to analyze and resolve problems
• Ability to document, plan, market, and execute programs
• Established project management skills

To comply with U.S. immigration and other legal requirements, it is necessary to specify the minimum number of years of experience required for roles based in the United States. For roles outside of the USA, to ensure compliance with applicable legislation, job descriptions should focus on the substantive level of experience required rather than specifying a minimum number of years. We will not sponsor individuals for employment visas, now or in the future, for this job opening.