Senior Regulatory Affairs Specialist

Integra LifeSciences

Sr. Regulatory Affairs Specialist developing and implementing regulatory strategies for product registration in Asia Pacific and Latin America.

Posted 4/28/2026full-time🇫🇷 FranceSeniorWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

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Hard Skills & Tools

regulatory strategiesregulatory plansregulatory submissionsproduct approvalsregulatory registration projectsrisk identification in regulatory strategiesknowledge of medical device regulations

Soft Skills

strong writing skillsstrong communication skillsattention to detailmulti-taskingteam collaborationrelationship building

Certifications

Bachelor's degree