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Global Regulatory Support / Project Management

Deerfield, Illinois | Sciences
Job ID: 71809
Listed on 5/26/2017

Global Regulatory Support / Project Management


Job Description: 
1. Represent Global Regulatory Affairs during cross-functional core team meetings (CTM). 
a. Active participation in CTM and associated ancillary meetings (as necessary) 
b. Follow-up discussions with team members and associated sourcing of information and decisions. 
i. Individual / small group discussions and or communications. 
2. Responsible for collection and distribution of deliverables required for global regulatory filings with R&D, manufacturing , QA, Medical and other applicable departments. 
a. Lead Global Regulatory Team meetings – Regional interactions LATAM, APAC, North America and EU. 
b. Obtain clarity on requested country RA deliverables. 
i. Including new country RA deliverable requests associated with changes in project scope. 
c. Effectively communicate deliverable requirements to team. 
d. Manage status of requested deliverables 
e. Conduct review and assessment of deliverables provided by team prior to presentation to countries 
i. Assessment conducted to determine suitability of deliverable for regulatory filing. 
f. Address subsequent follow-up queries from countries. Obtain clarity and/or revised documentation from team (as necessary) 
3. Global Regulatory Affairs Project Management 
a. Diligent maintenance of tracking tools and repository of country submission deliverables. 
i. LIBRA Master Spreadsheet 
ii. Master Schedule - annexes 
iii. Global RA strategy / plan updates – Biologic and Device 
iv. TPFG (Third Party Finished Goods) deliverable spreadsheets 
v. Country submission files 
vi. Global RA core deliverables – product specifications, Certificates, quality agreements, labeling, etc. 

Skill Set Requirements: 
• Experienced in the registration and maintenance of regulatory licensures for globally marketed medical device products. 
• Knowledgeable in global medical device regulations. 
• Ability to assess the acceptability of quality, preclinical and clinical documentation for global submission filings. 
• Effectively communicate and collaborate with regional regulatory personnel and cross functional team members. 
• Demonstrated attention to detail and organizational skills. 
• Quality background highly desirable.