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 future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist will develop and implement global regulatory strategies based on international regulations to register Integra’s products in Asia Pacific and Latin America. This individual prepares on time medical device submissions and facilitates timely regulatory clearances/approvals. This individual represents regulatory affairs for new products registrations, changes in intended use and product/design changes as well as manufacturing transfers for Latin America/Asia Pacific markets. This individual works with their manager to prioritize regulatory workload based on compliance and business objectives. This individual works with their manager to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance. RESPONSIBILITIES Supports International Regulatory Director in developing partnerships with global franchise leaders, commercial leaders, sales managers and LA/APAC distributors to ensure timely product clearances and/or approvals. Represent LA/APAC regulatory affairs on project planning and project teams. Working with department management provides LA/APAC regulatory guidance to cross-functional groups. Develops and coordinates LA/APAC 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-Pacific/Latin America regions. Manages regulatory registration projects and maintains list of product approvals for Asia Pacific/Latin America regions. Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company. Perform 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 well as a member of the team and build relationships between RA and other areas of the organization Able to identify risk in Regulatory strategies Ability to speak another LA/APAC language a plus Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Apply To This Job