Clinical Research Regulatory Affairs Manager Job Listing at Kelly Services in South San Francisco, CA (Job ID US3583401_BH9894979)

Description

Kelly® Science & Clinical is seeking a Regulatory Affairs Manager for a direct-hire position at a cutting-edge client in South San Francisco, CA . If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Manager, Regulatory Affairs

At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte – whether it be in one of our labs, corporate offices, the field – enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a results-driven environment that values innovation, collaboration, and compassion.

The Position:
We are looking for an energetic and self-motivated Regulatory Affairs professional who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre-market development activities with a key focus on in vitro diagnostic systems including assay, software and hardware. This role also offers the opportunity to work alongside the IVD Quality team in the development and implementation of processes for the regulatory affairs department that comply with internal, domestic, and international quality regulations.

The position requires a person with commitment to excellence, and the ability to work in a fast-paced, technically skilled, team setting.

This is a hybrid role (in office at least 3 days a week) and is based out of our headquarters in South San Francisco (SSF), California, United States.  We are also open to remote if candidate is located in the West Coast.

The Regulatory Affairs Manager or Sr Manager will report to the Senior Director of Global Regulatory Affairs (located in the EU) and will be a key member of the global RA department.

• Seeks expert advice and develops device regulatory product strategies and identifies data and information requirements as needed by the project.
• Key RA representative and leader on product development teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or national regulations.
• Provides regulatory guidance to product development teams regarding design, development, validation and risk management.
• Manages the preparation of technical documents for review by regulatory bodies, and revises these to enable effective presentation of data and strategy to regulatory agencies.
• Supports third party on-site audits and inspections
• Stays abreast of regulatory procedures and changes in regulatory climate. Within the Global RA team, analyzes legislation and guidance and shares updates to organization under limited supervision.
• Develops, implements and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in internal initiatives
• Develops and assists in implementing and maintaining regulatory processes in accordance with IVDR, MDSAP etc.
• Represents RA on project initiatives with other groups to drive efficiencies across the company.

Who You Are:

• Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related life sciences
• Required Experience: 5+ years of regulatory experience in IVD, companion diagnostics, medical devices (Preferred experience: 7+ years of pre-market regulatory experience in IVD industry)
• Demonstrated hands-on experience in preparing regulatory clearance/approvals for IVD products in the EU, USA, OUS; (Preferred experience: working experience with IVD submissions under IVDR Regulations is highly desirable)
• Solid working knowledge of global regulatory requirements related to in-vitro diagnostics systems, laboratory automation and software / hardware components of IVD medical devices.
• Strong communication skills, both oral and written.
• Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts on complex projects.
• Must have highly effective organizational and planning skills to apply daily in a multidisciplinary environment.
• Able to work with minimal supervision in a fast-paced environment
• Proficient in Microsoft Office Suite.

Location:

• This full-time position is located in South San Francisco (hybrid, 3 days in office)
• Minimum travel requirements, up to 10% domestic travel if required
• This position reports to the Senior Director of Global Regulatory Affairs who resides in the EU

Pay range
$148,400—$162,400 USD
 

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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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