Stryker Corporation Careers – Senior Specialist

Job Description:

Develop and apply intermediate knowledge and understanding of regulatory requirements, legislation, processes and procedures to support new product development and product lifecycle activities. Act as a liaison between the division and in country regulatory representatives to enable and maintain global market access. Acts as a catalyst for globalization. Viewed as departmental resource.

Job Responsibilities:

• Develops and applies intermediate technical leadership skills to plan and implement activities in support of global regulatory strategy, submissions and renewals
• Assesses regulatory intelligence to develop intermediate regulatory knowledge and contribute to the development of global regulatory strategies, providing regulatory input to new product development and product lifecycle planning
• Supports the New Product Submission Planning process for worldwide product registrations.
• Demonstrates developing project management, regulatory writing, coordination, and execution skills, with emphasis on regulatory submissions and maintenance activities.
• Recommends changes in procedures when indicated including ways to incorporate global requirements.
• Acts as a point of contact for Regulatory teams in global distribution networks.
• Plans, conducts and executes assignments, reviewing progress and evaluating results.

Job Requirements:

• Typically a minimum of 3 years experience
• RAC certification preferred
• B.S. or B.A. Degree required.
• Basic to intermediate understanding of quality system regulations, medical device legislation and other regulations related to global market access preferred.
• Candidates with multilingual communication skills preferred

Job Details:

Company:  Stryker

Vacancy Type:  Full Time

Job Location: Indianapolis, IN, US

Application Deadline: N/A

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