Senior Regulatory Affairs Specialist, NPD Job Listing at Kelly Services in Sunnyvale, CA (Job ID US3539151_BH9746455)

Description

Kelly® Science & Clinical is currently recruiting for a Senior Regulatory Affairs Specialist for a 2-year contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA location. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.
Workplace: Remote (USA)
Position Title: Senior Regulatory Affairs Associate, New Product Development
Pay rate: $50-55/hour  
Company: Kelly® Science & Clinical
Overview
The Regulatory Affairs Senior Specialist II, NPD 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.
Responsibilities

• Identifies RA project deliverables and contributes to development of the project master schedule
• Authors and prepares regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan
• Ensures proper filing and organization of all documents and correspondence in support of and concerning all regulatory submissions
• Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status
• Reviews and interprets regulatory intelligence information.  Shares RI with RA and other cross functional teams and provides training to other associates as needed.
• Uses best practices and knowledge of internal or external business issues to improve products or service
• Works independently, receives minimal guidance. Acts as a resource for colleagues with less experience.
• Provides regulatory leadership to NPD core team including advising on regulatory impact of product or business decisions
• Uses regulatory and scientific knowledge to prepare pre-submissions. Shares and interprets pre-sub feedback with core team and provides guidance on changes needed to intended use, product design or verification and validation plans and protocols.
• Interact with regulatory authority/ health agencies to address queries during review
• Provides core team with emerging regulatory intelligence information as it relates to the product in development

Qualifications

• 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
• Ability to prioritize, multi-task, and organize work.
• Ability to succeed in a fast-paced environment with the ability to be flexible and adaptable within a dynamic environment
• Detail oriented with good analytical skills
• Good organizational skills with attention to detail and accuracy
• Basic project management and interpersonal skills and the ability to understand scientific concepts
• Strong oral and written communication and presentation skills
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat
• Interact with global regulatory leaders and peers to expedite approval of pending registrations        
• Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
• Maintain a "focused urgency" as required by specific events
• Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
• Assess potential impact and/or applicability to other related areas 
• Assess corrective action to assure it prevents recurrence 
• Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions
• 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
• Act as a resource for colleagues with less experience, may lead small projects with manageable risks and resource requirements.

Preferred

• Serving as the Regulatory lead (full core team member) on project core teams
• Actively participating in project core teams, developing regulatory plans and collaboratively achieving project goals and meet timelines with moderate to complex risks and resources requirements
• Partnering with global and regional marketing in the development of regulatory plans
• Partnering with Clinical Affairs and R&D in the development of clinical strategy and analytical plans respectively
• Formulating short-term planning for individual deliverables and participate in long term planning within the organization
• Compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions
• Actively managing and monitoring submissions under review. Respond promptly and negotiate with regulatory authorities, as needed. Track and manage regulatory review timelines
• Conducting post-market changes assessment
• Supporting design changes and sustainment projects
•  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

Why Join Us:

• Competitive compensation package and potential for permanent placement following the temporary period.
• Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
• Access to ongoing career development and networking opportunities through Kelly® Science & Clinical's expansive network of industry experts and recruiters.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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