Regulatory Affairs Specialist
Posting ID: JP-002660114
-Define worldwide regulatory requirements necessary for regulatory approval of assigned products.
-Participate on cross functional teams as regulatory lead
-Complete worldwide regulatory assessments and strategies as required to support assigned projects and provide direction to project teams to support strategic new product development and product modifications as required
-Provide direction on application of external standards for assigned projects as required.
-Execute product submission strategies as directed
-Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages
-Review technical documentation, i.e., test reports, test protocols, etc., for scientific validity and compliance to regulatory standards. Review includes using scientific judgement to guide cross functional teams
-Rigorous documentation for all phases of regulatory submissions, including priority setting, requirements research, documentation gathering, submission writing, project schedules, approvals, renewals, and change orders
-Provide guidance and oversight to team members related to regulatory compliance
-Review company marketing literature for compliance to applicable regulations
-Maintain a thorough knowledge of current QSR and ISO requirements as they apply
-Experience and working knowledge of MDD and EU MDR
-Subject Matter Expert (SME) external regulatory audits
-Interact with external regulatory vendors
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072