Regulatory Affairs Specialist II
Regulatory Affairs Specialist II
Posted on :
17-07-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
17-07-2025
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.
- Determine regulatory pathways and formulate regulatory strategies for the U.S. market.
- Assess regulatory impact on design materials labeling packaging manufacturing processes and facility changes.
- 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.
- Build relationships and interface with cross-functional teams (Engineering Manufacturing Marketing etc.).
- Build and conduct regular training in software development software as a medical device and cybersecurity.
- 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.
- Support responses to regulatory body inquiries and support audits by regulatory bodies.
- Review and understand global regulatory requirements (FDA TGA EU MDD MDR Health Canada etc.)
- Provide mentoring to junior level positions.
- 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.
- Familiarity with IEC 62304 ISO 13485 and FDA Part 11 compliance for software validation.
- Experience with EU MDR requirements for software and app-based devices (Annex I & XIII).
- Effective collaboration with software clinical and human factors team.
- Post-market compliance expertise including UDI vigilance and software change reporting.
- Strong understanding of cybersecurity requirements and guidance (e.g. FDA IMDRF).
- 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) products.
- 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.
- Proven leadership and negotiation skills works well with all levels able to successfully manage cross-departmental expectations.
- Excellent written and verbal communication skills.
Employment Type
Full-time
Key Skills
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