Project Manager, Regulatory Affairs 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.
  • Goal-oriented engineers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
  • 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

  • Works independently with general supervision of the Regulatory Affairs Department Manager, Senior Manager, Director, or Senior Director:
  • Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
  • Record detailed customer requirements, constraints, and assumptions with stakeholders to establish the project deliverables.
  • Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
  • Ensure a common understanding by setting expectations in accordance with the project plan to align the stakeholders and team members.
  • Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
  • Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
  • Responsible to improve team performance by building team cohesiveness, leading and motivating to facilitate cooperation, ensure project efficiency, and boost morale.
  • Measure project performance using appropriate tools and techniques to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
  • May coordinate the activities of one or more exempt and/or non-exempt employees.
  • 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
  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  • Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

Experience/skills required

  • BA or BS (emphasis in management or related discipline preferred) or equivalent.
  • PMP certification or equivalent (i.e. PRINCE2) desired.
  • RAC certification preferred.
  • 3 years demonstrated project management experience in at least one discipline (RA, R&D, Operations, PMO, etc.), with, typically, a minimum of 7 years of Regulatory Affairs medical industry experience, preferably with medical devices.
  • Demonstrated ability to manage global cross-functional projects to successful completion
  • Demonstrated expertise in the effective application of project management tools such as MS Project, SharePoint, and Visio
  • Excellent interpersonal communication, collaborative team work, and negotiation skills
  • Demonstrated ability to plan and conduct meetings
  • Demonstrated experience presenting to management and ability to build trusting relationships
  • Knowledge of the Quality System Regulations (21 CFR) and European Medical Device Regulations and other equivalent regulations related to Pre-Market Clearance/Approval for medical devices or pharmaceuticals
  • Demonstrated ability to comply with constantly changing procedures and prioritize work effectively.
  • Ability to generate and explain detailed proposals, schedules, financial data, objectives, and other documentation accurately.
  • Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities
  • Effective research and analytical skills.
  • Proficiency with Microsoft Office.
  • Effective written and oral communication, technical writing and editing skills.
  • Ability to work independently with minimal supervision.
  • Preferably:

  • Has a thorough understanding of FDA and international medical device regulations or pharmaceuticals.
  • General understanding of product development process and design control.

Work From Home: Not available

Travel Percentage: 20%

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