Senior Regulatory Affairs Specialist – Lingo (on-site)

Abbott • Alameda, CA

1d • $90,000 - $180,000 • Onsite

About The Position

The 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. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

Requirements

• Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
• Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
• Ability to work effectively on cross-functional teams.
• Must be able to juggle multiple and competing priorities
• Ability to identify and solve problems and work independently with little oversight.
• Strong written, verbal, presentation, and organizational skills.
• Working knowledge of FDA QSR.

Nice To Haves

• Advanced degree in Engineering, Sciences, or related discipline
• Previous experience with 510(k)/PMA submissions or class I / II exempt software devices
• Experience with software medical devices
• 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
• Has a sound knowledge of a variety of alternatives and their impact on the business.

Responsibilities

• 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.
• Prepares 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.
• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Influences middle management on technical or business solutions.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior