Sr. Regulatory Affairs Specialist

Position Description:


Responsible for developing regulatory strategies, preparing U.S. and international 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, internal audits and inspections for FDA 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 PMA (Pre-Market Approval) or 510(k) submissions for US Class III or Class II medical devices. Work on MDD (Medical Device Directive) design dossiers, technical files and change notifications or Design History Files. Responsible for total product life-cycle regulatory activities to include pre-clinical, clinical, approval, post-approval and obsolescence. Navigate complex government and industry regulations to include US Food Drug and Cosmetic Act and relevant Medical Device Regulations to include 21 CFR Parts 11, 803, 806, 807, 814, 822, 830, and 860. Ensure product adherence to Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42/EEC), Canadian Medical Device Regulation (CMDR), ISO 13485 and ISO 14971. Multiple positions available. This position is open to telecommuting from anywhere in the United States.

Basic Qualifications:


Requires a Master’s degree in Regulatory Affairs, Biomedical Engineering, or closely related field; and 2 years’ experience as a Regulatory Affairs Specialist or related occupation in Regulatory Affairs. Must possess at least 2 years’ experience with each of the following: Pre-Market Approval or 510(k) submissions for US Class III or Class II medical devices; MDD design dossiers, technical files and change notifications, or Design History Files; Total product life-cycle regulatory activities to include pre-clinical, clinical, approval, post-approval, and obsolescence; 21 CFR Parts 11, 803, 806, 807, 814, 822, 830, and 860; and QSR 21 CFR 820, EU MDD 93/42/EEC, CMDR, ISO 13485, and ISO 14971. Multiple positions available. This position is open to telecommuting from anywhere in the United States.