Associate Manager - Regulatory Affairs in Gurugram bei Stryker Corporation

Datum der Veröffentlichung: 10/5/2020

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:

  • 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%

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