GRC Analyst supporting ISO27001 certification preparation at Asiera. Collaborating with technical teams for documentation and compliance.
About the role
- Senior Regulatory Affairs Specialist in the Endoscopy Business Unit. Supporting global regulatory strategies and compliance for medical devices based in Flower Mound, Texas.
Responsibilities
- Support new product development and sustaining for both US and OUS global regulatory release through the development and execution of regulatory strategies.
- Support the total product lifecycle by assessing changes made to the device post-launch to determine the regulatory impact of changes.
- Ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA, Notified Bodies and other regulatory bodies.
- Evaluate engineering changes to existing products to determine regulatory impact.
- Create and update regulatory deliverables as needed.
- Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
- Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
- Evaluate proposed products for regulatory classification and jurisdiction.
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to regulatory groups and others within the organization.
- Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.
- Help train stakeholders on current and new regulatory requirements to ensure organization wide compliance.
- Assist other departments in the development of SOPs to ensure regulatory compliance.
- Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
- Review collateral material associated with new launches and ongoing product support.
Requirements
- Bachelor’s degree (B.S. or B.A.) required
- 2+ years of working in an FDA regulated industry
- 2+ years of medical device regulatory affairs experience
- Previous experience with Class I and II Medical Devices
- Bachelor's degree in Engineering, Biological Sciences or equivalent focus
- RAC certification or Advanced Degree (Masters in Regulatory Affairs or Engineering)
- Previous experience with software Medical Devices
- Experience interacting with regulatory agencies
- Demonstrated success in management of global regulatory strategy and submission activities
- Applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations)
- Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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