Primary

• Develop/advise company on regulatory strategies for new medical device products and modifications to existing products in alignment with applicable regulations and business needs.
• Support product development and sustaining engineering projects by providing regulatory guidance for hardware and software projects, technical document review & feedback, provide appropriate design control requirements for differing development phases (including labeling).
• Lead pre-market submissions to relevant authorities (e.g., letters to file, significant change assessments, pre-submissions, 510(k)s, Canada medical device license applications).
• Technical File/Regulatory Documentation creation, maintenance, and audit support, including the clinical evaluation report.
• Effectively interface with internal stakeholders and external regulatory authorities and other technical resources (e.g., FDA, Notified Body, Health Canada, external consultants) for regulatory and technical document management.
• Monitor applicable regulatory requirements; assure compliance with internal and external standards.
• Conduct risk management activities: hazard analysis, risk analysis, identify and evaluate risk control measures for supported projects.
• Follow documented procedures for all activities related to the Company’s Quality System.
• Support other areas of the Quality System and perform other tasks as defined by Management.

Secondary

• Ensure, and support as needed, effective and efficient post-market surveillance (e.g., clinical evaluation reports, post-market surveillance reporting, health hazard assessments).
• Support as needed, the effective and efficient processing of any assigned CAPAs.

Education

• Bachelor’s degree or equivalent in technical discipline, such as engineering, biology, chemistry, healthcare; Master’s degree, or equivalent.
• Regulatory Affairs Certification (e.g., RAC) preferred.

Work Experience

• Minimum of seven (7) plus years of progressive experience in medical device regulatory affairs. Quality assurance and quality engineering experience desirable.
• Successful preparation and submission of 510(k)s and/or international submissions and registrations.
• Strong working knowledge of US and international medical device regulations and standards, including 21 CFR (e.g., 820, 803, 806, 807), MDD/MDR, ISO 13485, CMDR, MDSAP, ISO 14971, IEC 60601, IEC 62304, IEC 62366.
• Experience with developmental best practices for medical device hardware and software, including electromechanical medical devices and both embedded and non-embedded software. Experience with artificial intelligence and SaMD preferred.

Other

• Strong oral and written communication and presentation skills. \
• Demonstrated interpersonal skills including strong negotiation skills.
• Excellent writing skills to develop clear and logical information and conclusions based on design documentation
• Organized self-starter, able to work in a fast-paced environment.
• Ability to work independently and as part of team, strong collaborative skills.
• Proficient in Microsoft Office, Adobe Acrobat, and other business software.