Director of Regulatory Affairs

3 days ago

Apply Now

Receive Emails with Similar Jobs

Powerful Medical

WebsiteLinkedInAll Job Openings

technology • artificial intelligence • machine learning • medicine • research

51 - 200

Description

• Own the Regulatory area at Powerful Medical. • Ensure proper compliance and alignment with regulatory standards for certified products. • Lead certification of new products. • Manage regulatory submissions and approvals for medical devices. • Work with cross-functional teams and external consultants. • Prepare and coordinate regulatory submission filings for Class 2 devices. • Draft and file 510(k)s, De Novos, Q-subs, IDE requests and reports, and post-market reports. • Provide regulatory review for promotional materials and corporate presentations. • Own communication with regulatory bodies and coordinate audits. • Review and approve design control documentation and engineering change requests.

Requirements

• 5+ years of experience in regulatory affairs and quality management. • Biomedical, clinical or software engineering (or equivalent scientific discipline) to degree level. • In-depth knowledge of the US FDA and EU MDR regulatory landscape. • In depth knowledge 21 CFR 820, IEC 62304, ISO 62366-1, ISO 13485, and ISO 14971. • History of successful 510(k), De Novo's, IDE, and/or PMA device submissions. • Other worldwide submissions and clearances are a plus. • Experience with new product development projects for software as a medical device (SaMD) or medical device component. • Ability to review and provide critical feedback on design documentation. • A commercial focus in the application of regulatory requirements. • Excellent command of the English language. • Ability to communicate and interact with regulatory agencies and consultants. • Excellent project management skills. • Experience in growing and managing high-performing and multi-disciplinary teams. • Display, encourage, and inspire a culture of excellence across the entire organization.