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Compensation Not Specified
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Required Education None
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Required Experience Less than 1 year
Job Details
Requisition ID 536BR Job Title RA specialist Russia & CIS Group International Division EEMEA and India Business Unit EEMEA Headquarters Business Function Regulatory Affairs Country RUSSIAN FEDERATION City Moscow Employment Category Full Time Percent Travel Required None Shift 1st About Stryker Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. Job Description / Information For Russia and CIS region, the Regulatory Affairs Specialist is responsible for the implementation of international regulatory strategies and priorities as agreed among EEMEA Marketing, Corporate Regulatory, International Regulatory and country management. RESPONSIBILITIES • Support the international team by developing regulatory strategies and registration timelines; by monitoring and communicating regulatory intelligence and assessing its potential impact; by assuring that product to be registered meets country regulatory requirements; and by managing reimbursement matters, if applicable. • Develop proper working relationships with Ministries of Health across CIS region. • Obtain product registration dossiers from Divisions and tailor them to meet country registration requirements. Prepare and submit applications to Regulatory Agencies. • Coordinate communication among divisions, dealers, and health authorities in support of gaining regulatory approvals. • Assess proposed changes to registered products for their impact on product registration and importation. • Support post-market activities including product registration renewals, complaint reporting, and field actions. • Maintain records and tracking of registrations and registration activity • Develop and write SOPs in concert with corporate quality initiatives and guidelines. • Other duties may be assigned. Minimum Qualifications EXPERIENCE • At least 1-2 years experience in a international organizational business environment • Prior experience of product registration of Medical device • Any experience in a MD area (also operational environment, good understanding of MD business and processes) • Good understanding of local regulatory requirements for medical devices EDUCATION • Medical/business management degree. COMPETENCIES • English spoken and written for other language would be a plus • Strong project management skills • Excel operational • High ethical standards and integrity • Excellent interpersonal relationship building skills • Process consciousness • Good analytical and problem solving skills • Action oriented , achiever,