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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.