Director - RAQA

Position Summary

Director – RAQA and GA will report to the Vice President and General Manager, India and will be a key member of the India commercial leadership team.

Director – RAQA and GA will be responsible for leading and providing oversight to the Regulatory, Quality and Government affairs function.

Director – RAQA and GA will be responsible Leading a team of RAQA professionals who strive to increase the credibility and image of Stryker and the RAQA and GA function by providing expertise to support Stryker in achieving required outcomes for the business and customer

Director – RAQA and GA will work closely with India leadership team, APAC commercial team, Divisional RAQA, Corporate RAQA and GA leaders.

Essential duties & responsibilities:

Regulatory affairs

• Establish, optimize and execute India Regulatory strategies
• Build and maintain good relationships with CDSCO/India regulatory bodies, Bureau of Indian Standards 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
• Ensure India leadership team are across any relevant information or changes and promoting continuous quality improvement and engagement in quality initiatives which are in alignment with our company values
• Acts as a regulatory representative to influence, negotiate and support successful product submissions with government agencies and regulatory bodies
• 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
  
  

• Serve as Companys Management Representative
• Ensure Local Implementation, application, and maintenance of the companys quality system
• Lead preparation of Quality Reviews
• Lead monitoring and management review of Quality KPIs
• Develop and administer department budgets, schedules, and other administrative functions.
• Ensure Creation, update and application of procedural documents (SOPs)
• Lead preparation of internal and external audits, inspections, certifications and monitoring of associated CAPAs for manufacturing (QMS/GMP)
• Lead local Risk analysis
• Ensure appropriate Complaint management
• Ensure appropriate Deviation management
• Ensure implementation and monitoring of the distribution system (contracts, specifications, etc.)
• Ensure stock monitoring from a quality perspective (stock forecast, authorization to distribute, declaration in the event of a risk or confirmed shortage, transport conditions, batch recall, returns, etc.)
• Partner with Commercial teams on BD/M & A activities
  
  

• 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
• Establishes strategic alliances and influences direction of internal and external policies impacting the India business
  
  

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• Master of Pharmacy or equivalent Master degree in relevant field
  
  

• 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
• Experience in the areas of drugs, biologics, and combination products regulations is strongly preferred
  
  

• 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