You will own the Regulatory area at Powerful Medical. You will ensure proper compliance and alignment with regulatory standards for our already certified products and lead the certification of new ones. For this important role, we are looking for a seasoned professional, experienced with both MDR and FDA, who wants to impact one of the most important shifts in modern medicine.

Your role

• Lead the regulatory strategy of our innovative medical devices and own their regulatory submissions and approvals.

• Work with senior leadership, cross-functional teams and external consultants on regulatory strategy for US, EU, and international markets ensuring early consideration of regulatory requirements.

• Prepare and coordinate regulatory submission filings for Class 2 devices. Draft and file 510(k)s, De Novos well as pre-submissions (Q-subs), IDE requests and reports, and post-market reports.

• Support our product development and engineering team in the implementation of regulatory requirements, including preparation and review of design and test documentation, assessment of product changes, and interpretation of guidance and standards.

• Provide regulatory review/approval for promotional materials, press releases, and corporate presentations for compliance

• Maintain and expand current knowledge of FDA and international regulation, guidance and standards applicable to company products. Advise the company on any changes to Regulations or Standards that would affect our regulatory strategy or business objectives.

• Own communication with regulatory bodies, incl. FDA and EU Notified Body, and coordinate internal and external audits.

• Review and approve all design control documentation, engineering change requests for design, manufacturing, labeling changes, and product releases to ensure compliance with FDA, EU, and international government regulations.

Your profile

• 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.
• 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

Nice to have

• Knowledge of MDSAP and International regulatory experience in other leading markets, such as Australia, Canada, Japan, or Brazil

• Experience with AI/ML-based medical devices

• Experience with cardiology medical devices