GE HealthCare Sr Director - Regulatory Affairs 

India, Karnataka 

534550771

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. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Utilizes understanding of industry trends to inform decision making process.
Job Description

Roles and Responsibilities

• Roles and Responsibilities

• 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.

• Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work and influences for ease of doing business.

• Developing expertise within function. Growing reputation within the organization. Includes roles that are experts in their discipline, providing professional or thought leadership. Influences policy and ensures delivery within own function, linking with other functions of the organization.

• Manages a team of senior professionals. Requires specialized depth and/or breadth of expertise within their discipline. Requires strong commercial awareness and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.

• May lead functional teams or projects with moderate resource requirements, risk, and/or complexity. Presents business solutions to leaders in functional area. Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and may negotiate with external partners, vendors, or customers.

• Leads others to find creative solutions to address complex problems that may impact the organization. Has the ability to evaluate quality of information received and questions conflicting data for analysis. Uses multiple internal and external resources outside of own function to help arrive at a decision.

• Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.

• Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyse and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills.

• Involves working closely with Trade Associations and directly with regulators in shaping policies that are compliant and at the same time enhance ease of doing business. The role requires taking up leadership roles within trade associations, creating white papers, position papers on matters impacting healthcare industry.

• Work closely with regulators, Govt. departments such as AERB, CDSCO, BIS, MeiTY, MoEFCC etc.

Inclusion and Diversity

Ourare designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.