Regulatory Affairs Post Market Specialist

Job Description

Regulatory Affairs Post Market Specialist - Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group

Location: Remote/telecommuting from within the US

Note: sponsorship is not available for this position.

At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector.

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. This role will manage and coordinate analysis of post-market product feedback, complaints, adverse events, incidents, field reports, and other safety or performance issues for trend analysis and PMS reporting obligations. The Post-Market Surveillance Coordinator will lead a review of post-market surveillance processes and drive continual process improvement to maintain compliance to global market requirements.

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. 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.

About the Business:

Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery.

Preferred 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 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

• Experience leading process development

• 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 authoring submissions (510k, EU Technical Documentation, etc.) required

• 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

Responsibilities

What You’ll Do:

• 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

• Manage and contribute to the process design of post market surveillance activities

• 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

#LI-KA1

Disclaimer:

Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.

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

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.

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 - IC4

About Us

Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.

True innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

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Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.