Senior Regulatory Affairs Specialist

  Alameda, CA                   ·                Full time

Senior Regulatory Affairs Specialist

• iota Biosciences – Alameda, CA
• $116,500 – $142,000 a year

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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.

We are looking for a Senior Regulatory Affairs Specialist who is highly motivated and passionate to create and implement innovative regulatory strategies for novel Class III active implantable devices, support the day-to-day regulatory activities, and collaborate with cross-functional teams.

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

Additionally, the Sr. RAS will be expected to:

Responsibilities

• Provide regulatory support for new products/therapies
• Develop regulatory strategies that align with business goals
• Lead preparation of regulatory submissions for new products and product changes as required to ensure timely approvals
• Negotiate submission issues with agency personnel
• Lead cross-functional team efforts to resolve potential regulatory issues and questions from regulatory agencies
• Establish and maintain good relationships with agency personnel
• Maintain proficiency in worldwide regulatory requirements
• Monitor and interpret changes to regulatory requirements
• Assess impact to projects/processes and communicate this information to departments within the company that may be affected by these changes
• Create, review and revise SOPs, and other company and departmental procedures to ensure compliance
• Represent Regulatory Affairs on Material Review Board, CAPA Review Committee and Change Control Board
• Participate in the planning, conduct, and reporting for external audits as requested
• Take on miscellaneous projects as assigned

Key Qualifications:

• Bachelor’s degree in engineering, life sciences, or related medical/scientific field
• 3-4 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/communication skills
• Works well under pressure in a dynamic timeline-driven environment
• Ability to effectively manage multiple projects and priorities

Preferred Qualifications:

• Experience with US FDA
• Regulatory Affairs Certification (RAC) is a plus

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:

Health

• Employees thrive when healthy, both physically and mentally:
• Comprehensive health coverage for you and your family, covered at 100%
• Employee Assistance Program

Time-off

• Take time off when you need to take it:
• Generous PTO policy
• Paid parental leave
• Paid holidays beyond the traditional
• Paid volunteer day

Competitive Compensation

• In addition to our competitive base salaries, we offer:
• Annual Bonus Plan
• Long Term Incentive Plan (LTIP)
• 401k plan with matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation

Please click here to apply.