Senior Regulatory Affairs Specialist – Lingo (on-site)
About the role
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.
This is an exciting on-site opportunity at Lingo in Alameda, CA.
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
- Aid in 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
- Aid 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
Qualifications
- 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
Preferred Qualifications:
- 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
Required Qualifications:
- 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
- A sound knowledge of a variety of alternatives and their impact on the business
Benefits
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.