CONFIDENTIAL Senior Director North America Medical Device Regulatory Affairs – Health & Life Sciences Legal and Compliance Group

Manages the ongoing preparation, testing, and monitoring of compliance with government regulations and regulatory agencies as it relates to the design, development, and deployment of products and services.

The Senior Director, Risk Management and Regulatory Compliance, will coordinate closely with operations teams which may include Global Business Units, Corporate Security, and with Oracle Legal.  Responsibilities include designing comprehensive information security, and/or quality management, and regulatory oversight programs, including standards for product and service design aligned with Oracle Software Security Assurance and Security Architecture Review, and/or quality management system standards.  Will be responsible for managing information security risks, managing compliance team and evaluating and consolidating existing regulatory compliance functions.  Will educate through training members on information security and industry regulatory standards applicable to their products and services.  Work with respective teams which may include GBU development, operations, and service, to incorporate applicable industry regulatory standards, Oracle security and/or quality policies and customer-contractual obligations into processes and standards.  Work with Corporate Security and Business Assessment and Audit, and/or Quality System Internal Audit to evaluate product and service line security and regulatory compliance on an ongoing basis.  Work with Legal to evaluate changes in applicable laws and regulations and impact on products and services.  Work with Corporate Development and Legal to evaluate potential acquisitions for regulatory issues.  Coordinate industry and regulatory certifications, including managing certifications vendors (e.g., PCI, HIPAA, HITECH, ISO).

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 in USD from: $139,400 to $291,800 per annum. May be eligible for bonus, equity, and compensation deferral.

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. 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.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance

The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.

Career Level - M5

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