RAQA - Specialist in Kayseri at Stryker Corporation

Date Posted: 11/5/2020

Job Snapshot

Job Description

This is an Exciting time to join Stryker as a RAQA Specialist you will;

Co-ordinate and prepare document packages for regulatory submissions from all areas of the organization. Collect all materials required in submissions, license renewal, and annual registrations. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Works on problems of complex scope where data analysis requires evaluation of specific factors. Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

Pre-Market:

Advise responsible personnel on regulatory requirements for clinical studies and/or marketing applications, evaluation of regulatory filing strategies, and assessment of resulting documentation for compliant with regulatory and corporate requirements.

Coordinate and execute pre-approval compliance activities and the preparation, review, and submission of regulatory filings.

Monitor impact of changing regulations.

Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Participate in internal/external audits.

Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation. •

Post-Market:

Ensure compliance with product post-marketing approval requirements.

Review and approve advertising/promotional items, product labelling, and product claims to ensure compliance with regulatory requirements.

Identify product-associated problems and develop proposals for solutions.

Provide regulatory input to support compliant resolution of production issues.

Participate in internal/external audits.

Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.

Desired Talent Themes

Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

Work From Home: Regularly scheduled days

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