Principal Regulatory Affairs

Responsibilities

• Develop and execute US Regulatory Strategies for product development and submissions, ensuring alignment with global regulations and standards.
• Collaborate with multiple stakeholders across Hamilton Medical.
• The initial focus of this role will be to ensure that regulatory files are compliant for 510(k), de Novo and PMA submissions; identify gaps in product documentation from 21 CFR Parts 800-1299 and EU MDR requirements; and ensure regulatory files are compliant with US regulatory requirements.
• Compliance Oversight: Maintain compliance with relevant regulations, standards, and guidelines throughout the product lifecycle, including assisting with documentation of post-market surveillance data.
• Aid in preparing responses to US regulatory authorities' questions within assigned timelines.
• Recommend changes for clinical protocols for US regulatory compliance.
• Recommend strategies for earliest possible approvals of clinical trial applications in US, including strategies for IDE submissions and IRB requests.
• Assist in preparing clinical trial site ethics review board/FDA applications for investigational device trials.
• Review interim or final reports for trial site ethics boards/FDA as required.
• Risk Assessment: Conduct risk assessments on devices and collaborate with product development teams to mitigate potential regulatory risks per the requirements of the applicable version of ISO 14971. Provide input to risk documentation files from post-market surveillance data.
• Labeling and Packaging: Ensure product labeling and packaging comply with applicable US regulatory requirements.
• Communication: Act as a liaison between the Company and FDA or other regulatory authorities. Respond to inquiries and requests for information in a timely manner with complete and accurate information.
• Participate in the required Project Team (P-Team): providing functional expertise and guidance in P-Team. Defining and executing tactical implementation plans. Interfacing with other workstreams and cross-functional stakeholders.
• Perform coordination and preparation of document packages for audits and inspections from all areas of company, providing regulatory input to minimize potential for findings of non-compliance.
• Training and Guidance: Provide guidance and training to cross-functional teams on regulatory requirements and updates to raise US requirements knowledge within the Company.
• Regulatory Intelligence: Stay abreast of regulatory procedures and changes in regulations, standards, and industry trends to anticipate and adapt to evolving requirements.

Qualifications

• Strong knowledge of FDA medical device regulations (21 CFR 801, 807, 812, 814, 820, 822, and 830), ISO standards (e.g., ISO 13485:2016 and ISO 14971:2019).
• Excellent knowledge of the applicable medical device regulations in various countries--including current developments (EU-MDR 2017/745) is an advantage.
• Knowledge of medical device regulations in MDSAP countries is an advantage.
• Ability to work collaboratively in a cross-functional team environment.
• Demonstrated ability to work constructively across all functions of the organization.
• Strong attention to detail and organizational abilities.
• Independent, reliable, and communicative personality for delivering high-quality work even under pressure, while handling multiple projects simultaneously.
• Bachelor's degree in a relevant scientific or engineering field required (advanced degree preferred).
• Minimum of ten years of experience in the medical device industry required with at least six years in regulatory affairs.
• Experience with 510(k) submissions and PMA applications required.
• Regulatory Affairs Certification (RAC) or other relevant certification by a recognized authority preferred (e.g., RAPS).
• Fluency in the English language required (both oral and written); German and any other language is an advantage.