Staff Engineer - Global Regulatory - Medical Devices in Gurugram bei Stryker Corporation

Datum der Veröffentlichung: 10/17/2020

Stellenauszug

Stellenbeschreibung

Who we want:

  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
  • Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
  • Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
  • Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.
  • Metrics-oriented managers. People who are always tracking important business metrics to ensure projects meet expectations and budget.

 What you will do:

  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies  
  • Participate in advocacy activities of a technical and/or tactical 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
  • Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
  • Negotiates with regulatory authorities throughout the product lifecycle
  • Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Assists other departments in the development of SOPs to ensure regulatory compliance
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams
  • Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
  • Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
  • Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
  • Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
  • Provides regulatory information and guidance for proposed product claims/labeling
  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
  • Monitors the progress of the regulatory authority review process through appropriate communications with the agency
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you need:

  • Educational qualification of BS in Engineering, Science,  or related degree; or MS in Regulatory Science
  • 6-8  Years of work Experience & having RAC Certification is preferred
  • Strong project management, writing, coordination, and execution of  regulatory items
  • Emphasis on technical and scientific regulatory activities.
  • Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance and distribution.
  • Under general supervision, plans, conducts and supervises assignments. 
  • Reviews progress and evaluates results.
  • Recommends changes in procedures.
  • Operates with appreciable latitude for un-reviewed action or decision.
  • Reviews progress with management. 
  • May direct work of Specialist or Sr. Specialist.
  • Seeks out diverse ideas, opinion, and insights and applies them in the workplace
  • Connects and relates well with people who think and act differently than oneself
  • Embraces scrutiny and accepts feedback as opportunity to learn and improve
  • Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
  • Navigates the dynamics, alliances, and competing requirements of the organization or business
  • Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities

Work From Home: Occasional

Travel Percentage: 20%

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