Sr. Regulatory Affairs Specialist in Gurugram at Stryker Corporation

Date Posted: 11/4/2019

Job Snapshot

Job Description

Seeking a passionate engineering professional with the following attributes:

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

Responsibilities and duties

Under direct supervision of the RA Project Manager or RA Department Manager/Sr. Manager/Director.

  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
  • 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

Experience/skills required

6+ years of relevant experience required

Work From Home: Not available

Travel Percentage: 20%

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