Medical Device Regulatory Affairs Specialist

About the position This role is for a Lead/Principal/Senior Regulatory Affairs Specialist in the med-tech space, playing a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. The specialist will collaborate with product engineering and development teams 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). Responsibilities include preparing documentation for global product registration, establishing partnerships to ensure compliance with regulatory requirements throughout the product lifecycle (development, launch, post-market), and defining regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance. The role primarily involves working with Oracle Health & Life Sciences business units but will also interact with other Oracle business units selling to the health and life sciences industries. The position requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape, acting as a collaborative, creative problem solver dedicated to excellence. The position is opened at the principal level, for 10+ years of experience, but one level lower (senior) and one level higher (lead) will also be considered.

Responsibilities

• Collaborate with product engineering and development teams on the total product lifecycle of AI-enabled, Cloud-native software applications.
• Prepare required documentation to register products in global markets.
• Establish strong partnerships to identify and ensure compliance with regulatory requirements throughout the product lifecycle.
• Define regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance.
• Work with Oracle Health & Life Sciences business units and interact with other Oracle business units selling to the health and life sciences industries.

Requirements

• 10+ years of experience (for Principal level; Senior and Lead levels will also be considered).
• Ability to keep up with the fast-paced environment of software development and an evolving regulatory landscape.
• Regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence.

Nice-to-haves

• BA/BS or advanced degree preferred.
• 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 Tech Files, etc.) required.
• Experience with sustaining and new product development is ideal.
• Experience interacting with notified bodies and/or regulators preferred.
• RAC, CQE, CPPS, CQA desired.
• Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations.
• Understands continual improvement and risk management.
• 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.

Benefits

• Flexible medical, life insurance, and retirement options.
• Volunteer programs.

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