Senior Regulatory Affairs Specialist

Join Us To Change Lives And Build Careers

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.

Responsibilities Include:

• Supporting the International Regulatory Director in developing partnerships with global franchise leaders, commercial leaders, sales managers, and APAC distributors to ensure timely product clearances and/or approvals.
• Representing APAC regulatory affairs on project planning and project teams.
• Providing APAC regulatory guidance to cross-functional groups in collaboration with department management.
• Developing and coordinating APAC regulatory strategies and regulatory plans.
• Communicating with international regulatory authorities in coordination with department management.
• Coordinating and preparing regulatory submissions according to country registration requirements to facilitate product approvals in APAC.
• Managing regulatory registration projects and maintaining a list of product approvals for APAC.
• Staying informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
• Performing other duties as assigned.

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.