Regulatory Affairs Senior Specialist, New Product Development

Danaher • New York, NY

3d • Remote

About The Position

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.
Learn about the Danaher Business System which makes everything possible.
The Regulatory Affairs Senior Specialist serves as the RA lead on New Product Development (NPD) core teams working on simple to medium complicated assay, instrument, software projects and/or system projects. This individual prepares the regulatory submissions and interacts cross-functionally to ensure on-time delivery (OTD) of product launches. This role offers exposure to diverse products and projects, DBS tools to implement continuous improvement, and drives introduction of new product availability while enhancing career growth within Regulatory Affairs.
The position reports to the Manager, Regulatory Affairs, and is part of the New Product Development (NPD) team located remotely with primary Core Teams in Sunnyvale, CA USA or Solna, Sweden.

Requirements

• Bachelor’s degree in field with 5+ years of related work experience OR Master's degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience
• In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products
• Experience supporting 510k submissions required, authoring compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) via eCopy or eSTAR and PMA submissions preferred.
• Ability to prioritize, multi-task, and organize work. Detail oriented with good analytical skills.
• Ability to succeed in a fast-paced environment with the ability to be flexible and adaptable within a dynamic environment

Nice To Haves

• Serving as a lead (full core team member) on project Core Teams
• Keeping abreast of changes of new or updated regulatory policies and issued guidance
• Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations

Responsibilities

• Identify key regulatory submission deliverables and contribute to the development of a project master schedule
• Prepare regulatory submissions including formal written technical reports
• Provide regulatory leadership to new product development teams to advise on impact of product or business decisions.
• Provide regulatory training to cross-functional groups
• Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed. Track and manage regulatory review timelines

Benefits

• Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees