Regulatory Affairs Post Market Specialist

About the role

The Regulatory Affairs Post Market Specialist supports the ongoing monitoring, evaluation, documentation, and escalation of product performance and safety information after launch. This role helps ensure that post-market signals are captured, assessed, and tracked, in accordance with regulatory requirements and internal procedures as part of the quality system.

Responsibilities

• Manage and contribute to the process design of post market surveillance activities
• Post market surveillance processes and activities related to product performance monitoring and reporting to meet medical device post-market requirements at all phases of the device lifecycle
• Support clinical evaluation and post-market surveillance processes through systematic literature surveillance, post-market data review, and integration of PMCF/Real World data into clinical evaluations, risk management files, and regulatory submissions
• Design cross-functional processes to generate safety and performance data to identify trends and early-warning signals in support of post-market activities
• Drive continual improvement activities and support quality processes to ensure compliance with all applicable regulations and requirements
• Collaborate with business partners to share feedback in order to improve product performance
• Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions as required
• Initiate and facilitate corrective or preventative actions as needed
• Enable compliant quality and regulatory communications for current products
• Support and participate in internal and external audits, risk management activities, and continual improvement
• Prepare and provide monthly reports to trend key quality measures as part of the post-market surveillance system
• Provide expertise to and coordinate across Quality, Marketing, Product Development, Clinical, and Regulatory staff in support of a robust post market surveillance system

Requirements

This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a Regulatory Affairs Post Market Surveillance Specialist who is collaborative, a creative problem solver, and dedicated to excellence in their work.

Qualifications

• BA/BS or advanced degree preferred
• 6+ years' experience in quality systems, post-market signaling, real world evidence tracking, regulatory reporting (or 4+ years with Master's)
• Experience authoring submissions (510k, EU Technical Documentation, etc.) required
• Experience leading process development
• Experience acting as a lead to resolve issues
• Demonstrated critical thinking skills focused on improved system performance outcomes and positive impact
• Excellent problem-solving skills; demonstrated application of structured problem-solving methods and tools
• Expertise in continual improvement and risk management
• Experience with advanced root cause analysis methods
• Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent
• Experience with sustaining and new product development is ideal
• Experience interacting with regulators preferred
• RAC, CQE, CPPS, or CQA certifications desired
• Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820, or other quality system regulations
• Excellent written and verbal communication skills
• Ability to adjust and adapt to changing priorities in a dynamic environment
• Ability to perform in a fast-paced and continually evolving business environment

Skills

Preferred qualifications include:

• BA/BS or advanced degree preferred
• 6+ years' experience in quality systems, post-market signaling, real world evidence tracking, regulatory reporting (or 4+ years with Master's)
• Experience authoring submissions (510k, EU Technical Documentation, etc.) required
• Experience leading process development
• Experience acting as a lead to resolve issues
• Demonstrated critical thinking skills focused on improved system performance outcomes and positive impact
• Excellent problem-solving skills; demonstrated application of structured problem-solving methods and tools
• Expertise in continual improvement and risk management
• Experience with advanced root cause analysis methods
• Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent
• Experience with sustaining and new product development is ideal
• Experience interacting with regulators preferred
• RAC, CQE, CPPS, or CQA certifications desired
• Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820, or other quality system regulations
• Excellent written and verbal communication skills
• Ability to adjust and adapt to changing priorities in a dynamic environment
• Ability to perform in a fast-paced and continually evolving business environment

Benefits

Oracle offers a comprehensive benefits package which includes:

• Medical, dental, and vision insurance, including expert medical opinion
• Short term disability and long term disability
• Life insurance and AD&D
• Supplemental life insurance (Employee/Spouse/Child)
• Health care and dependent care
• Flexible Spending Accounts
• Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
• 11 paid holidays
• Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
• Paid parental leave
• Adoption assistance
• Employee Stock Purchase Plan
• Financial planning and group legal
• Voluntary benefits including auto, homeowner and pet insurance

Pay

Hiring Range in USD from: $91,400 - $187,000 per year.

Schedule

Remote/telecommuting from within the US