Senior Regulatory Affairs Strategist

We are seeking an experienced Senior Regulatory Affairs Strategist to join our team!

The Medical Device team is responsible for assessing markets and products to ensure compliant market access for Medical Device Software Products. We work in collaboration with Product teams and subject matter experts to gather the vital documentation to register products in markets where the products are sold. Additionally, the team works with Product to perform ongoing post market surveillance activities.

Assists and supports the organization in complying with, as well as the ongoing preparation, testing and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies.

Career Level - IC3

Day to day responsibilities include but not limited to:

• Work in close collaboration with Development organizations to create and manage pre-market submissions across global markets ensuring compliance with regulatory authorities. 
• Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance.
• Maintenance of documentation and post market surveillance reporting are ongoing to maintain market authorization and require ongoing support for the assigned product teams. 
• Collaborate closely with fellow members of the Regulatory Affairs team to share insights, provide support, and ensure consistent adherence to regulatory standards and timelines.

Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Serve as a subject matter expert for internal clients with interpretation of applicable standards and regulations, and use of the quality management system. Update and maintain internal and externally facing documentation.  Coordinate and facilitate 3rd party audit activities.   Manage and compliance related projects for the GBUs.

Preferred Skills and Qualifications:

• 5-7 years of relevant experience
• BA/BS or advanced degree
• Regulatory Affairs Certification or CQE preferred
• Excellent written and verbal communication and presentation skills.
• Experience in working within a quality management system, preferably with ISO 9001, ISO 13485, or Quality System Regulations
• Understanding of continual improvement and risk management
• Ability to balance multiple projects/deliverables with close attention to detail.
• Project Management Skills

Does this sound like you? We would love to hear from you!

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Disclaimer:

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.

Range and benefit information provided in this posting are specific to the stated locations only

US: Hiring Range: from $70,600 to $141,300 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.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.

Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. 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.
9. 11 paid holidays
10. Pai