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Medical Device Regulatory Affairs Consultant

13 minutes ago

Dover, DE, United States Oracle Full time

About the Role:

In today's fast-evolving healthcare environment, where technology and regulations are continuously changing, we are looking for a skilled Regulatory Affairs Consultant in the medical device domain. As a leader in global health technology, Oracle is committed to maintaining a competitive edge and ensuring compliance with complex laws and regulations worldwide. Your expertise will be vital in navigating these challenges and driving our success in the healthcare and life sciences sectors.

As a Medical Device Regulatory Affairs Consultant, you will collaborate with product engineering and development teams on various AI-enabled, Cloud-native software applications utilized in clinical operations, clinical information systems, and decision support functionality. You will play a crucial role in preparing the necessary documentation for product registration in global markets and fostering strong relationships with business units to ensure compliance with regulatory standards throughout the product lifecycle.

This position emphasizes collaboration, creative problem-solving, and a dedication to excellence as you define regulatory strategies for product development, manage pre-market submissions, and oversee post-market activities. Join us to be at the forefront of healthcare innovation

About the Business:

Oracle's Healthcare and Life Sciences division leads the industry in providing tailored software and solutions for healthcare providers, payers, pharmaceutical companies, medical device firms, and clinical research organizations. Our offerings include advanced AI/ML solutions, cloud-based platforms, data analytics, electronic health records (EHR), and patient engagement systems. We strive to enhance patient outcomes, reduce costs, and accelerate innovation, enabling organizations to utilize data for informed decision-making while ensuring compliance with sensitive healthcare regulations.

What You'll Do:

  • Work closely with Oracle's product engineering teams to assess product functionality and develop effective regulatory strategies.
  • Collaborate across departments to manage and create pre-market submissions (including 510(k), CE Marking under EU MDR, Technical Files, applications to Health Canada, and other global submissions) that comply with regulatory authorities.
  • Maintain thorough documentation and conduct ongoing post-market surveillance to uphold market authorization.
  • Support internal and external audits to identify, evaluate, and address risks and deficiencies effectively.
  • Serve as a subject matter expert for internal teams regarding standards and regulations, and facilitate the use of our quality management system.
  • Manage compliance-related projects for health-related products.
  • Review and recommend modifications to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures for regulatory and quality compliance.
  • Stay updated on changing regulatory requirements that may impact our business, regulatory affairs function, and quality/compliance programs.

Preferred Qualifications:

  • BA/BS or advanced degree preferred.
  • Experience with Software as a Medical Device (SaMD) in regulatory affairs, quality compliance, or product development. Proven track record of authoring submissions (510(k), EU Technical Files, etc.) is essential.
  • Experience with notified bodies and/or regulators preferred.
  • Ability to thrive in a fast-paced, evolving business environment.
  • Relevant certifications such as RAC, CQE, CPPS, CQA are desirable.
  • Experience with quality management systems, preferably with ISO 13485, ISO 14971, 60601, or related regulations.
  • Understanding of continual improvement and risk management principles with excellent communication skills.
  • Flexibility to adapt to changing priorities in a dynamic environment.

Disclaimer:

Certain roles may require compliance with applicable health mandates.

Salary and Benefits:

The salary range for this role in the US is $87,000 to $178,100 annually, plus potential bonuses and equity. Oracle provides a comprehensive benefits package that includes medical, dental, and vision insurance, short and long-term disability, life insurance, 401(k) plans with company matches, flexible vacation, 11 paid holidays, paid sick leave, parental leave, and more.

This role will involve regular interactions with global colleagues, necessitating proficiency in English. Knowledge of French is beneficial.

Oracle is committed to fostering an inclusive workforce that reflects diversity in our communities and enables everyone to contribute. We welcome and encourage applicants from all backgrounds to apply.