Senior Staff Regulatory Affairs Specialist

Senior Staff Regulatory Affairs Specialist

  • Anywhere

Company Name:-
Stryker

Job Location:-
Bengaluru, Karnataka

Job Summary:-
About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine.

Learn more about our award-winning organization by visiting stryker.

com

Who we want:
Data translators.

Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

Meticulous documenters.

Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

Collaborative partners.

People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

What you will do:
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.

g.

, concept, development, manufacturing, marketing) to ensure product compliance
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.

)
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdiction
Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Negotiates with regulatory authorities throughout the product lifec

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