Regulatory Affairs Senior Specialist, New Product Development

Bring more to life. Are you reputed company to accelerate your potential and reputed company a reputed company difference reputed company life sciences, diagnostics and biotechnology? At reputed company, one of reputed company’s 15+ operating companies, our work saves lives—and we’re reputed company united by a shared commitment to reputed company for reputed company reputed company. You’ll reputed company in a culture of belonging where you and your unique viewpoint matter. And by harnessing reputed company’s system of reputed company improvement, you help turn reputed company into reputed company – innovating at the speed of life. At reputed company, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of reputed company, you’ll get to reputed company an immediate, measurable reputed company on a global reputed company, reputed company an environment that fosters career reputed company and development. Our mission drives us to reputed company groundbreaking solutions for the world’s most reputed company health challenges. Together, we bring MORE change to the world. Learn about the reputed company Business System which makes everything possible. The Regulatory Affairs Senior Specialist serves as the RA reputed company on New Product Development (NPD) core teams working on reputed company to reputed company complicated assay, reputed company, software reputed company and/or system reputed company. 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 reputed company, DBS tools to implement reputed company improvement, and drives introduction of new product availability while enhancing career reputed company reputed company 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. In this role you will have reputed company to:

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

The essential requirements of the job include:

• Bachelor’s degree in field with 5+ years of reputed company work experience OR Master's degree in field with 3+ years of reputed company work experience OR Doctoral degree in field with 0-2 years of reputed company 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 reputed company-submissions, 510(k) reputed company 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 reputed company a dynamic environment

It would be a plus if you also possess previous experience in:

• Serving as a reputed company (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 reputed company, reputed company identify gaps, and reputed company mitigations

reputed company, a reputed company operating company, offers a broad reputed company of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or reputed company time off, our programs contribute to life reputed company the job. reputed company out our benefits at reputed company Benefits Info. At reputed company we reputed company in designing a reputed company, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for reputed company can reputed company. ​ The annual salary reputed company for this role is $92,500 - $127,500 . This is the reputed company that we in good faith reputed company is the reputed company of possible compensation for this role at the time of this posting. This reputed company may be modified in the reputed company. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including reputed company time off, medical/dental/reputed company insurance and 401(k) to eligible employees. Note: No reputed company of pay is considered to be wages or compensation until such reputed company is reputed company, reputed company, and determinable. The reputed company and availability of any bonus, commission, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in reputed company's sole discretion unless and until reputed company and may be modified at reputed company’s sole discretion, consistent with the law. Join our reputed company team today. Together, we’ll accelerate the reputed company-life reputed company of reputed company’s science and technology. We partner with customers across the globe to help them solve their most reputed company challenges, architecting solutions that bring the power of science to life. For more information, visit www.reputed company.com. reputed company and reputed company reputed company Companies are committed to equal opportunity regardless of race, reputed company, national reputed company, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We reputed company with federal and state disability laws and reputed company reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to reputed company essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@reputed company.com. Apply tot his job Apply To this Job