As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device)

• You will help prepare the required documentation to register products in global markets where the products are sold
• You will establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope
• You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising / promotion, etc.), as applicable
• You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries
• This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape
• Work closely with Oracle’s product engineering teams to assess product functionality and develop regulatory strategy

Collaborate cross-functionally with other teams to create and manage pre-market submissions (including 510(k), CE Marking under EU MDR, Technical Files, applications to Health Canada, and other global submissions) across global market ensuring compliance with regulatory authorities

• Maintain documentation and post market surveillance report on an ongoing basis to maintain market authorization
• Support internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies
• Serve as a subject matter expert for internal clients with interpretation of applicable standards and regulations, and use of the quality management system
• Manage and compliance related projects for Health-related products
• Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance
• Maintain compliance with changing regulatory requirements across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs

This role will be working on a regular basis with colleagues around the world

• For this role we are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work
• Experience authoring submissions (510k, EU Tech Files, etc.) required
• Experience with sustaining and new product development is ideal
• Ability to perform in a fast-paced and continually evolving business environment
• Understands continual improvement and risk management
• Excellent written and verbal communication skills
• Ability to adjust and adapt to changing priorities in a dynamic environment
• Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates
• To support this collaboration, knowledge of English is required for this role

Proficiency in French is required for candidates residing in Quebec, otherwise it is considered an asset

Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations

• CA: Hiring Range in CAD from: $78,500 to $128,500 per annum
• US: Hiring Range in USD from: $87,000 to $178,100 per annum
• May be eligible for bonus and equity
• Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle’s differing products, industries and lines of business
• Oracle US offers a comprehensive benefits package which includes the following:
• 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
• Pre-tax commuter and parking benefits
• 401(k) Savings and Investment Plan with company match
• 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

We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options