Regulatory Affairs Director ISA

GE HealthCare; Bengaluru; On-site; INR 3,000,000 - 5,400,000; Full time

Job summary

GE HealthCare is seeking a senior regulatory affairs leader to guide regulatory strategy for global product launches, registrations and post-market compliance. You will collaborate with regulators across multiple jurisdictions to ensure timely approvals and sustained compliance.

In this role you will build expertise, lead senior professionals, and influence policy; you will interact with trade bodies and regulators to shape policies that ease doing business while protecting patient safety.

Qualifications

• This role requires significant experience in the Quality & Regulatory Affairs with minimum 17+ years of experience in QARA.
• Knowledge level is comparable to a Master's degree from an accredited university or college ( or a high school diploma with relevant experience).

Responsibilities

• Provides regulatory strategy and direction for regulatory requirements for product launch, premarket submissions/registrations and post-market compliance across regulators.
• Interprets business challenges and recommends best practices to improve products, processes or services.
• Leads teams of senior professionals and influences policy formulation within the function.
• Manages resources and negotiates with internal and external partners to deliver compliant solutions.

Skills

Regulatory strategy

Regulatory leadership

Stakeholder management

Communication skills

Education

Master's degree in Quality & Regulatory Affairs

Job description

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. 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.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world

Job Description

Roles and Responsibilities

• 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.
• 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.

Required Qualifications

• This role requires significant experience in the Quality & Regulatory Affairs with minimum 17+ years of experience in QARA
• Knowledge level is comparable to a Master's degree from an accredited university or college ( or a high school diploma with relevant experience).

Desired Characteristics

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

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are 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.

Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https://www.ge.com/careers/fraud

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Additional Information

Relocation Assistance Provided: No