Regulatory Affairs Specialist II
Regulatory Affairs Specialist II
Posted on :
27-06-2025
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1 Vacancy
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Job Description
Responsibilities:
- Responsibilities include developing regulatory strategies reviewing design input/output documentation identification of applicable standards and guidance documents performing regulatory assessments to determine the impact of design/process changes preparing regulatory submissions maintaining regulatory filings and licenses and interacting with regulatory agencies.
- Serve as the global regulatory liaison and primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware.
- Maintain expert knowledge of appropriate regulations legislation best practices and guidelines related to Artificial Intelligence Software as a Medical Device and Machine Learning (SaMD/ML).
- Provide regulatory guidance to product teams develop regulatory strategies and review and approve product design control documentation.
- Author and lead regulatory documentation and submissions including (but not limited to) U.S.
- FDA 510(k) premarket notifications De Novo applications internal Letters to File and pre-submissions with minimal supervision.
- Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
- Provide risk-based guidance and regulatory input to projects and issues ensuring cross-functional alignment and resolution.
- Collaborate with international counterparts to support global regulatory submissions approvals and implementation rollouts.
- Perform timely reviews of collateral Marketing material for responsible product lines.
- Build relationships and interface with cross-functional teams (Engineering Manufacturing Marketing etc.).
- Assess impact of changes to applicable laws and regulations and identify impact to the business and in collaboration with other stakeholders develop strategies to address such changes.
- Review and understand global regulatory requirements (FDA TGA EU MDD MDR Health Canada etc.).
- Bachelors degree (Engineering Biology or Regulatory Science) and a minimum of 3 year(s) related experience or equivalent combination of education and experience Proven experience with software as a medical device (SaMD) and mobile health app regulations.
- In-depth knowledge of FDA guidance on digital health cybersecurity and mobile medical apps.
- Track record of 510(k)/De Novo submissions for connected orthopedic or wearable devices.
- Experience with EU MDR requirements for software and app-based devices (Annex I & XIII).
- Regulatory strategy development for Bluetooth/Wi-Fi enabled orthopedic technologies.
- Effective collaboration with software clinical and human factors teams.
- Post-market compliance expertise including UDI vigilance and software change reporting.
- Strong understanding of cybersecurity requirements and guidance (e.g. FDA IMDRF).
- RAC certification or equivalent with ongoing education in digital health regulations.
- Knowledge of US and/or international regulatory requirements (FDA TGA EU MDD MDR Health Canada etc.).
- Direct experience with regulatory submissions for Artificial Intelligence Software as a Medical Device and Machine Learning (SaMD/ML) product.
- Understanding of orthopaedic devices.
- Excellent attention to detail and proven organizational skills able to prioritize and multi-task and see projects/assignments to completion.
- Proficiency in Excel Word PowerPoint Outlook and customer database management systems.
- Excellent written and verbal communication skills.
- Less than 15% of overnight travel; potential for either domestic or international travel.
Employment Type
Full Time
Key Skills
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