Job Information
Stryker Director-GAMA & RA in Gurugram, India
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Position Summary
Director - GAMA & RA will report to the Vice President and General Manager, India and will be a key member of the India commercial leadership team.
Director - GAMA & RA will be responsible for leading and providing oversight to the Regulatory and Government affairs function.
Director - GAMA & RA will work closely with India leadership team, APAC commercial team, Divisional RAQA,and GAMA leaders.
Essential duties & responsibilities:
Government Affairs
Be a custodian of Stryker's brand among key Government stakeholders, academic institutions, trade associations and industry peers
Identification, engagement, coordination, and representation with stakeholders in the public policy ecosystem to bring forth Stryker's position with the relevant external stakeholders on policy areas of impact.
Identify, Analyze, develop positions, and drive advocacy on policy and regulatory issues pertinent to Stryker's business in India.
Work with cross functional teams to develop positions around medical device policy, Innovation and R&D, trade & pricing
Develop and manage trusted relationships with key influencers or experts, Government officials, academia, industry peers and Trade associations.
Continuing to strengthen and build Market access and Health economics capabilities
Work closely with teams engaged in CSR, Communications and Marketing to plan and support interactions and events that engage external government and industry leaders to support Stryker's Corporate Responsibility initiatives
Work with both internal and external stakeholders to gather information and attend to any issues that affect/ impact Stryker's business operations
Build relationship and network with regional and global GA teams
Regulatory affairs
Establish, optimize and execute India Regulatory strategies
Build and maintain good relationships with CDSCO/India regulatory bodies and industry associations to achieve optimal outcomes for approval of new products and maintenance of existing products.
Lead the registration strategy and process for existing and new products planned to be launched in India
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
Develop and lead the annual New product submission planning process in collaboration with commercial leaders
Build regional and global network and relationships to ensure adequate/required support for meeting registration timelines
Develop and execute 5-year regulatory affairs strategy
Identify and lead process improvement opportunities and also participate in global process improvement initiatives as lead for India
Lead product field action/recalls if any
Be the lead for all things relating to RAQA and GA for global team
Partner with Commercial teams on BD/M & A activities
Qualifications & experience:
Qualifications:
- Master of Pharmacy or equivalent Master degree in relevant field
Experience:
Typically, a minimum of 12-14 years' experience
5 plus years of people management or 2-3 years of leadership exp
Medical device/Healthcare experience a must
Work Knowledge, skills & abilities
Strong interpersonal skills, problem solving character
Very hands-on, Process driven and ability to stay focused and delivering high quality outcomes
Team player, Inclusive and collaborative
Forceful in decision making process
Good communicator
Results oriented with the determination and perseverance to drive results within a matrix environment and globally oriented company
Ability to build relationships and collaborate at all levels of the organization and across multiple functions
Strong financial and analytical skills
Absolute personal integrity and honesty.
Operate effectively in a multi-disciplinary matrix environment
Willingness to accept variety of assignments, highly motivated, with a natural ability to perform under stress
Project management, writing, coordination, and execution of regulatory items
Self starter and comfortable taking lead
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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