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 clinical trials
- 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
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