Senior Regulatory Affairs Specialist

Job description

Position Description: Responsible for developing regulatory strategies, preparing U.S. regulatory submissions, and obtaining and maintaining approval for products and therapies to markets worldwide. Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy. Prepare document packages for regulatory submissions from all areas of company and inspections for Food and Drug Administration Quality Systems Regulation (QSR). Compile all materials required in submissions, license renewal and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Work on 510(k) submissions for US Class II medical devices. Work on EU MDD (Medical Device Directive) technical files and/or EU Medical Device Regulation (MDR) technical documentation and support the review of other Device History File (DHF) or EU deliverables including Clinical Evaluation Reports, Post-Market Clinical Follow Up, Risk Management, and Design Verification/Validation. Responsible for total product life-cycle regulatory activities including product development, obtain...