Principal International Regulatory Product Specialist - Diabetes Care (on-site)

About the role

This Principal International Regulatory Operations Specialist will work on-site at our Alameda, CA location in the Diabetes Care Division. The role focuses on supporting regulatory processes and ensuring compliance with relevant regulations.

Responsibilities

• Contribute regulatory input to product and process change plans triggered by new or revised regulations/standards
• Ensure affected dossiers, technical documentation, labeling, and procedures are updated on time
• Cook up and maintain a structured horizon-scanning log for priority jurisdictions
• Lead or co-lead cross-functional working sessions to document decisions, actions, and closure evidence, track progress against external compliance dates
• 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 market access 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 and deliver clear gap assessments with closure plans and evidence
• Maintain annual licenses, registrations, listings (as applicable)
• Assist compliance with product post-marketing approval requirements
• 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
• Support knowledge sharing by facilitating training and providing guidance to peers on new/updated requirements

Requirements

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)

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
• Experience collaborating across QA, R&D, Clinical, Labeling, and Operations; may consider strong cross-functional experience with demonstrable regulatory change leadership
• 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; experience with Veeva Vault and dashboarding/automation (e.g., reminders/escalations) is a plus
• 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

Pay

$100,000.00 – $200,000.00