Associate Manager GAMA & BIS
Stryker
- Gurgaon, Haryana
- Permanent
- Full-time
- Be a custodian of Stryker’s brand among key Government stakeholders, academic institutions, trade associations and industry peers
- Identify, Analyze, develop positions, and drive advocacy on political, policy and regulatory issues pertinent to Stryker’s business in India.
- Develop and manage trusted relationships with key influencers or experts, Government officials, academia, industry peers and Trade associations.
- 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.
- Work with cross functional teams (legal, sales, communications, marketing, R&D etc.) to develop positions around medical device policy, Innovation and R&D, trade & pricing policy, public procurement policy, regulatory issues and local government issues.
- Engage with law enforcement agencies and civic authorities as and when required
- Advocate market access for new and upcoming therapies of Stryker
- Work towards insurance inclusion and coverage for Stryker therapies and products
- Conduct research & analysis of policy documents and draft position papers, advocacy materials, collaterals on policy and regulatory issues.
- 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
- Conduct comprehensive assessments of BIS standards relevant to our product categories,
- Interpret and analyze BIS regulations, guidelines, and directives to determine their impact on our product design, manufacturing, and distribution processes.
- Liason with BIS office and provide technical inputs on BIS draft standards
- Standard Gap assessment of BIS Standard and identify the test requirement to mitigate the gap
- Conduct comprehensive assessments of BIS standards relevant to our product categories, including medical devices and equipment.
- Interpret and analyze BIS regulations, guidelines, and directives to determine their impact on our product design, manufacturing, and distribution processes.
- Cross functional collaboration with SGTC , Divisional regulatory and standard teams for proposed standard review and inputs
- Managing product testing with the BIS certified lab as pe the gap identified
- Lead the implementation of strategies and initiatives to align our products with BIS standards, including design modifications, testing protocols, and documentation requirements.
- Establish processes and procedures to monitor ongoing compliance with BIS regulations and address any non-conformities or deviations promptly.
- Bachelor's degree in Engineering( Biomedical engineering, Science, or related field; advanced degree preferred.
- 5+ years of experience in regulatory affairs, quality assurance, or project management within the medical technology or healthcare industry.
- In-depth knowledge of Bureau of Indian Standards (BIS) regulations and requirements for medical devices and equipment.
- Proven track record of successfully leading projects related to regulatory compliance and standards alignment.
- Strong analytical skills and attention to detail, with the ability to interpret complex regulations and translate them into actionable strategies.
- Excellent communication and stakeholder management skills, with the ability to influence and collaborate effectively across functional teams.
- Knowledge of MDD 93/42/EEC and ERC requirements is good to have