Regulatory Affairs Specialist

Regulatory Affairs – Regulatory Affairs            ·            1020 Atlantic Avenue, Suite 100 Alameda, Ca 94501 (Hybrid)              ·            Full time

iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.

iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic.

In this role, you will be supporting multiple FDA pre-submissions and IDE submissions through writing, reviewing, and supporting conference calls with FDA.

To be successful in this role, we believe that you are a structured and analytical person with a high sense of responsibility, who also looks for ways to assist the team with a hunger to improve. As the ideal candidate, you will be able to build relationships with your colleagues, as well as be flexible, and able to shift focus quickly.

Responsibilities

• Manage the preparation and quality check of regulatory submissions and reports to ensure they are compiled and approved in a timely manner
• Assist in the communication with FDA
• Provide regulatory assessments for manufacturing, design changes, and validation activities
• Archive and maintain regulatory affairs documents to support compliance with regulatory requirements
• Ensure regulatory compliance with internal procedures and external standards.
• Identify guidance documents, international standards and consensus standards, and assist product development teams with their interpretation
• Provide expertise in translating regulatory requirements into practical, workable solutions

Key Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related medical/scientific field 
• Class III Medical Device experience required
• Regulatory Affairs Certification (RAC) is a plus 
• Three to four years of regulatory experience in medical device industry 
• Experience in writing/preparing submissions for medical devices (PMA, 510(k)), IDE)  
• Technically savvy; must be able to discuss and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues 
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results 
• Organized, efficient, process-oriented; high attention to detail 
• Effective interpersonal and communication skills 
• Works well under pressure in a dynamic timeline-driven environment 
• Ability to effectively manage multiple projects and priorities

Preferred Qualifications:

• Experience preparing technical documents and submission dossiers
• Experience with US FDA

$90,000 – $110,000 a year

At iota Biosciences, we take pride in providing equal employment opportunities to everyone, inclusive of race, ethnicity, beliefs, religion, marital status, gender, gender identity, citizenship status, age, veteran status or disability.

iota offers a very competitive benefits package that includes the following:

• 100% employer-paid Anthem Platinum PPO or Kaiser Platinum plans, as well as dental, and vision, for employees and dependents at 100%
• Short-Term and Long-Term Disability
• Employee Assistance Program
• 401k plan – matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation
• Bonus Plan
• Long Term Incentive Plan (LTIP)
• Four weeks of vacation, two floating holidays, and nine company paid holidays

Please click here to apply.