Associate Manager - Regulatory Affairs in Gurugram at Stryker Corporation

Date Posted: 10/5/2020

Job Snapshot

Job Description

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:

  • Manage and lead the Regulatory team for Joint Replacement at Stryker Global Technology Center. Hires, trains, supervises, motivates, and develops staff; manages schedules and workflow. Responsibility includes Communications business site located in Germany.
  • Accountable for regulatory strategy, deliverables, and results to support new product development and product registration for International markets.
  • Accountable for post market regulatory compliance including complaint handling, adverse event reporting, recall decisions, reporting, and execution.
  • Provide regulatory guidance to and interact with cross functional business partners including R&D, Marketing, Quality, Operations, Legal and Compliance.
  • Stay abreast of regulatory standards/guidances and communicate relevant information within the business.
  • Support Quality System activities including NC/CAPA, Internal Audit, and change control.
  • Manages regulatory project implementation and other development activities.
  • Completes other regulatory activities as assigned by immediate supervisor/Department Head.

What you need:

  • 10+ Years of work Experience with Education: B. Tech / B.E/M.Tech/ M.S. in Engineering or Science preferred
  • Working knowledge of Medical Device Regulations (FDA & EU required, international a plus)
  • Ability to manage all Regulatory Systems including MDR reporting and recalls, CAPAs, listing and registration requirements, 510k and new product development requirements, complaints systems.
  • RAC certification preferred
  • Regulatory affairs experience in the Medical Device industry or related industry is required.
  • Demonstrated proficiency in managing and motivating subordinates.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Work with other divisional regulatory leads to ensure compliance and standardization across divisions
  • Willing to work with multiple time zones and stakeholders
  • Competence in subordinates’ duties and tasks
  • Ability to work with all levels of management
  • Strong organizational, problem-solving, and analytical skills
  • Ability to manage priorities / workflow of multiple projects while meeting deadlines
  • Proven leadership and business acumen skills
  • Understanding of CE file and CE dossier requirements
  • Good judgment with the ability to make timely and sound decisions.
  • Creative, flexible, and innovative team player.
  • Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
  • Must be able to communicate with large groups of people.
  • Ability to work in a fast paced, constantly changing work environment.
  • Commitment to excellence and high standards.
  • Acute attention to detail.
  • Demonstrated ability to plan and organize projects.
  • Proficient on Microsoft Office (Word, Excel, Access and PowerPoint).
  • Excellent written and oral communication skills

Work From Home: Occasional

Travel Percentage: 10%

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team