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.

• Supports 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. 
• Represent APAC regulatory affairs on project planning and project teams.
• Working with department management provides APAC regulatory guidance to cross-functional groups.
• Develops and coordinates 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 APAC.
• Manages regulatory registration projects and maintains list of product approvals for APAC.
• Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
• Perform 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.