Associate Manager GAMA & BIS

Work Flexibility: Hybrid or Onsite

Objective –

This position is responsible for two areas:

1.Driving government affairs and market access initiatives which will support Stryker’s brand in India and create opportunities for Stryker’s business growth by responsibly navigating the social, political, and economic issues

2. Lead BIS project to ensure Stryker reviews and aligns BIS standards for Stryker portfolio to ensure  compliance with applicable BIS standard requirements, ISO Standard requirements and improvement and harmonization.

What this person will do?

Govt Affairs and Market access

• 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

BIS project lead:

• 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.

Qualifications/Skill requirements:

• 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