Director of Regulatory Affairs

Quality & Regulatory       ·        Hayward, CA       ·       Full time

Description

The Director of Regulatory Affairs is responsible for leading and actively participating in RefleXion’ s efforts to obtain product approvals. The incumbent combines knowledge of scientific, regulatory, and business issues to enable products that are developed to meet required regulatory requirements. The Director of Regulatory Affairs identifies information needed, obtains supporting data and ensures that the information is effectively presented for the registration of products worldwide.  

The Director of Regulatory Affairs also provides effective direction and guidance to R&D, manufacturing, clinical, and marketing/sales regarding changing regulatory requirements and standards.

Responsibilities

• Leads in reviewing, writing and preparing the high-level strategy for regulatory submissions and filings required for U.S. FDA and other regulatory bodies (e.g., Notified Bodies for CE marking, Health Canada Licenses, etc.) as needed
• Manages regulatory submission logistics
• Evaluates changes to products for impact on global regulatory approvals
• Supervises efforts to monitor impact of changing regulations on submission strategies and updates internal stakeholders
• Supports product development teams with regards to implementation of international regulatory requirements and standards
• Participates in strategy discussions with other internal functions related to new products (Clinical Affairs, External Innovation, Reimbursement), provides regulatory input into their plans, support with any needed regulatory submissions
• Responsible for working with the appropriate internal groups to report adverse events to regulatory agencies and internal stakeholders
• Maintains and updates regulatory affairs procedures utilizing the change control process
• Other duties as assigned

Minimum Qualifications

• 5 or more years of experience in medical device regulatory affairs with direct project management responsibilities and a PhD in science or engineering, or similar field OR 8 or more years of experience and a master’s degree OR 10 or more years of experience and a bachelor’s degree required.
• Excellent project management, planning and change management skills
• The ability to recruit, lead and develop a lean, talented
• Effective and sustainable leadership and collaboration across organizational boundaries
• Familiarity with test methods and standards for the design, verification, and validation of medical device products is required.
• Experience with medical device software products for both pre-and-post market.
• Experience in the development, writing and submittal of successful 510(k)/PMA/De Novo submissions, including leading interactions with FDA
• Must have prior working experience with application processes for 510(k)s, Health Canada Applications or CE Mark applications and technical files
• Knowledge of electromechanical medical devices, or complex software-driven medical devices is required
• Excellent attention to detail
• Excellent verbal (including presentation) and written communication skills, especially technical report writing, required
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
• Excellent organizational and negotiation skills

Company Benefits and Perks – What you will love about us!

All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture.  As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store! 

• The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
• Competitive compensation and stock option package
• Medical (both HMO and PPO options), Dental and Vision
• Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
• Employee Assistance Program (EAP)
• 401K
• 3 Weeks/Year PTO Accrual rate to start
• Employer paid Life Insurance
• RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items
• Daily on-site lunches
• Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
• Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials and monthly Book Club
• On-site mobile car wash services weekly
• Electric car charging stations on site

Please click here to apply.