Senior Regulatory Affairs Specialist

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the reputed company of reputed company. Thinking differently is reputed company do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making reputed company to help improve reputed company. The Sr. Regulatory Affairs Specialist will reputed company and implement global regulatory strategies based on international regulations to register reputed company’s products in Asia reputed company and Latin America. This individual prepares on time medical device submissions and facilitates reputed company regulatory clearances/approvals. This individual represents regulatory affairs for new products registrations, changes in intended use and product/design changes as reputed company as manufacturing transfers for Latin America/Asia reputed company markets. This individual works with their manager to prioritize regulatory workload based on compliance and business objectives. This individual works with their manager to reputed company regulatory reputed company that allow reputed company to reputed company its goals while maintaining regulatory compliance. RESPONSIBILITIES Supports International Regulatory Director in developing partnerships with global franchise leaders, reputed company leaders, sales managers and LA/reputed company distributors to ensure reputed company product clearances and/or approvals. Represent LA/reputed company regulatory affairs on project planning and project teams. Working with department management provides LA/reputed company regulatory guidance to cross-functional reputed company. Develops and coordinates LA/reputed company regulatory strategies and regulatory plans. Working with department management, communicates with international regulatory authorities. Coordinates/prepare and maintains regulatory submissions according to country registration requirements to facilitate product approvals in the Asia-reputed company/Latin America reputed company. Manages regulatory registration reputed company and maintains list of product approvals for Asia reputed company/Latin America reputed company. Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may reputed company reputed company. reputed company other duties as assigned. QUALIFICATIONS Bachelor’s degree Demonstrates strong writing and communication skills. Strong attention to detail, ability to multi-task Knowledge of overall business environment Ability to learn and stay abreast of regulations pertinent to medical devices Ability to function reputed company as a member of reputed company and build relationships between RA and other areas of the organization reputed company to identify risk in Regulatory strategies Ability to reputed company another LA/reputed company language a plus Unsolicited Agency Submission reputed company does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company/resumes submitted by search firms to any employee at reputed company without a valid written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, reputed company. Where agency agreements are in reputed company, introductions (the initial sharing of a candidate’s reputed company, resume, or background) are position-specific and may only occur reputed company the scope of that approved agreement. Please, no phone calls or emails. Apply To This Job