Manager, Regulatory Affairs

Description

Job Responsibilities

Defines and implements regulatory strategies and priorities. Is able to discern when features and enhancements require and do not require registrations. Analyzes risk vs. benefit in regulatory strategies for manufacturing changes to ensure successful review by regulatory authorities. Negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met.

Manages the preparation and review of registration packages and responses to deficiency letters to ensure effective data presentation and quality. Maintains an awareness of global legislation and assesses its impact on the business and product development programs. Creates systems to assure regulatory compliance, and strives to ensure that products remain in compliance. Author, with team members, key pieces of regulatory submissions.

Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams. Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams.

Evaluates manufacturing and labeling changes and promotional materials for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.

Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs. Proposes new/revised policies and recommends standard interpretation of global regulations.

Requirements

A minimum of 3 years experience working in a Regulatory Affairs positions in the Medical Device sector

Knowledge of international regulations including Asia, EU, Canada and Latin America

Knowledge of 510K submissions

4 year degree

Nice to have

Master degree

Regulatory Affairs Certification

Local to Chicago

We're actively interviewing for this position right now, so send through your resume to be considered. If this position isn't a good match for your profile but you would be interested in hearing about Regulatory Affairs roles in the Midwest please send your resume and I'll get in touch.

To find out more about Real please visit www.realstaffing.com