JOB SUMMARY

This position supports international registrations through work with internal and external stakeholders. The Associate Regulatory Project Manager is responsible for serving as the primary corporate point of contact for international regulatory affairs, product divisions, legal operations and state and federal governmental organizations.

MAJOR RESPONSIBILITIES

Primary Divisional Point of Contact for International Registrations with Medline product divisions. Collect documentation, negotiate timelines and facilitate discussion for additional testing or supporting material required.

Coordinate Corporate Legal and Compliance review for regulatory documentation needed to support international registrations and new business opportunities.

Support registrations by requesting and providing Certificates of Foreign Government (CFG) and other services to include Notary and Apostille documentation as required per assigned product family/division.

Support labeling and product change control requirements for products registered in international markets.

Identify issues and risks that might delay a registration and make recommendations or develop contingency plans.

Assist in the review and development of processes related to regulatory activities of responsibility. Suggest process improvements to make documentation and registrations more efficient.

MINIMUM JOB REQUIREMENTS

Education

B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.

Work Experience

2 years of regulatory or quality experience in the medical device industry or pharmaceutical industry.

Additional

Willing to travel up to 10% of the time for business purposes.