Lead Regulatory Affairs - Boise, United States - Idaho State Job Bank

Description

Lead Regulatory Affairs & Compliance Strategist at Oracle in Boise, Idaho, United States Job Description Job Description We are seeking an experienced Regulatory Compliance Specialist 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.

Regulatory Compliance Specialist as a part of a team to support the organization in Medical Device program development which includes new product development as well as new market research and development.

+ Assess Global Medical Device regulations to develop regulatory strategies and roadmaps.

+ Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance + Serve as an intermediary between the organization and regulatory authorities ensuring coordination with internal and external stakeholders in the preparation of regulatory dossiers.

+ Identify regulatory risks and propose mitigations in collaboration with cross-functional teams as appropriate. + Support and actively engage with team members by sharing best practices to ensure regulatory compliance. Career Level

• IC4 Responsibilities 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.

Preferred Skills and Qualifications:
years of relevant experience + BA/BS or advanced degree + Regulatory Affairs Certification or CQE preferred + Excellent written and verbal com To view full details and how to apply, please login or create a Job Seeker account