Job title: Staff Regulatory Affairs Specialist

Company: Stryker

Job description: Work Flexibility: Hybrid

Who we want

• 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.
• 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

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 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

Education / Work Experience:

• BS in Engineering, Science, or related degree; or MS in Regulatory Science
• Typically a minimum of 6- years’ experience
• MS or RAC(s) preferred

Knowledge / Competencies:

• 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, postmarketing 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 unreviewed 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

Travel Percentage: 10%

Expected salary:

Location: Gurgaon, Haryana

Job date: Thu, 03 Feb 2022 00:14:31 GMT

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