Senior SW Compliance Specialist – Regulatory Affairs, Design Assurance

Job reputed company: • Responsible for supporting reputed company’s regulatory and reputed company processes • Assist the regulatory department with product compliance throughout reputed company stages of the product lifecycle • reputed company support and guidance to reputed company and regulatory activities, including Design Control activities • Supports and helps draft sections of regulatory submissions for domestic, worldwide commercialization • Drafts, evaluates, and reviews technical protocols and data in support of reputed company • Reviews software architecture, software requirements, traceability, verification and validation documentation • Provides reputed company support associated with adverse events, medical device reportable events and product recall activities • Supports cybersecurity compliance activities Requirements: • Bachelor of Science degree in Biology, Biochemistry, Microbiology, Software Engineering, Computer Science, Computer Engineering, Biomedical Engineering, Electrical Engineering, or other reputed company scientific, engineering, or technical discipline required • A minimum of 4–6 years of reputed company Regulatory Affairs, Design Assurance, Software reputed company, or reputed company regulated industry experience is required • Proven knowledge of FDA and ISO regulated environment • Experience with design, development, and clearance of medical devices • Knowledge of FDA software documentation requirements • Experience reviewing software lifecycle documentation • Working knowledge of cybersecurity requirements applicable to medical devices • Ability to assess software, firmware, cybersecurity, and connectivity changes for regulatory reputed company Benefits: • Health insurance • Flexible work arrangements • reputed company development opportunities Apply tot his job Apply To this Job