Senior International Regulatory Product Specialist – Diabetes Care (on-site)

The Opportunity

This Senior International Regulatory Operations Specialist will work on-site at our Alameda, CA location in the Diabetes Care Division.

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.

We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment.

The individual may execute tasks and play a consultative role by partnering across business functions. This new team member assists in identifying emerging regulations, interpreting them and ensuring that they are effectively presented to different stakeholders across the organization.

Additionally, may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

What You’ll Work On

• Assist in SOP development and review
• Provide regulatory input to product lifecycle planning.
• Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand, investigate, and evaluate regulatory history / background of class, disease / therapeutic / diagnostic context in order to assess regulatory implications for approval.
• Determine trade issues to anticipate regulatory obstacles.
• Determine and communicate submission and approval requirements.
• Participate in risk benefit analysis for regulatory compliance.
• Assess the acceptability of documentation for gap assessments submitted.
• Monitor impact of changing regulations on submission strategies.
• Maintain annual licenses, registrations, listings and patent information.
• Assist compliance with product post-marketing approval requirements.
• Assess external communications relative to regulations.
• Review regulatory aspects of contracts.
• Assist with label development and review for compliance before release.
• Contribute to the development and functioning of the crisis / issue management program.
• Provide regulatory input for product recalls and recall communications.

Required Qualifications

• Bachelor’s degree
• 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals, Pharma). Note : Higher education may compensate for years of experience.
• Regulatory history, guidelines, policies, standards, practices, requirements and precedents
• Regulatory agency structure, processes and key personnel
• Principles and requirements of applicable product laws
• Submission / registration types and requirements GxPs (GCPs, GLPs, GMPs)
• International treaties and regional, national, local and territorial trade requirements, agreements and considerations
• Domestic and international regulatory guidelines, policies and regulations
• Ethical guidelines of the regulatory profession, clinical research and regulatory process
• Pay strong attention to detail, think analytically and organize and track complex information
• Manage projects and create project plans and timelines
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Has broad knowledge of various technical alternatives and their potential impact on the business
• Exercise good and ethical judgment within policy and regulations
• Use in-depth knowledge of business functions and cross group dependencies / relationships
• Define regulatory strategy with supervision
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues

Preferred Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development / support, engineering, scientific affairs, operations, or related area.
• Advanced level degree
• Experience with EU and other international medical device / drugs / pharma regulations and submissions.
• Experience with design controls in medical devices, IVDR, Pharma industries
• Proficient with Excel and PowerPoint and presenting information to leadership
• Previous experience working in a highly matrixed and geographically diverse business environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
30+ days ago