Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist

About the Role Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.

What You'll Do

• Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices
• Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance
• Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input
• Assist with promotional content development and review for compliance before distribution
• Lead Regulatory Affairs Ad & Promo SOP development and review
• Prepare robust regulatory applications/submissions to regulatory authorities
• Assist in SOP development and review in support of "next-gen" product offerings
• Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action
• Utilize technical regulatory skills to propose strategies on complex issues
• Ensure compliance with product post-marketing requirements
• Review product labeling to ensure compliance with relevant regulatory requirements
• The role may involve limited work direction to peers and the ability to influence middle management on technical or business solutions
• Establishes and cultivates an extensive network of support to facilitate completion of assignments

What We're Looking For

• Bachelor's Degree; preferably in biology, chemistry, microbiology, immunology, medical technology, etc
• Minimum 2 years regulatory experience and/or 2 years relevant industrial experience (quality, product-development/support, scientific affairs)
• Advanced degree in Engineering, Sciences, or related discipline (preferred)
• Previous experience with 510(k)/PMA submissions or Class I/II exempt software devices (preferred)
• Experience with software medical devices (preferred)
• 4-6 years’ experience in a regulated industry (regulatory area preferred but may consider QA, software or systems R&D, or related area)
• Ability to work effectively on cross-functional teams; multitask and manage competing priorities
• Strong written, verbal, presentation, and organizational skills
• Working knowledge of FDA QSR
• Sound knowledge of a variety of alternatives and their impact on the business
• Ability to work independently with little oversight

Nice to Have

Compensation & Benefits

• Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives
• Health Investment Plan (HIP) PPO medical plan eligibility in the next calendar year
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• Abbott recognized as a great place to work in dozens of countries and admired company by Fortune
• Equal Opportunity Employer; commitment to employee diversity
• On-site role at Lingo in Alameda, CA