Regulatory Affairs Specialist Job at Kelly Services, Sunnyvale, CA

bmhFd1FTa0piTm5iYVlkOUh1MkVGSjRCZWc9PQ==
  • Kelly Services
  • Sunnyvale, CA

Job Description

Regulatory Affairs Senior Specialist, Global Market Protection

Location : Remote

Shift : M-F, standard working hours

Pay : $47-50/hr

1 year contract role

Overview:

The Regulatory Affairs Senior Specialist is responsible for serving as the RA lead on product lifecycle management project teams. This role includes completing regulatory reporting assessments for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position offers the opportunity to advise project teams on regulatory impacts, devise compliance strategies, and liaise with regulatory bodies during audits. This is a remote position.

Responsibilities:

  • Serve as the lead on product lifecycle management project teams, supporting cross-functional stakeholders in reporting assessments for product and facility changes.

  • Act as the lead for QMS/Compliance activities, such as audits, Post Market Surveillance, Nonconformances (NC), Corrective and Preventative Actions (CAPA), Field Actions, and complaints.

  • Collaborate cross-functionally to understand changes, impacts, and implementation requirements in global regions and with the WHO to meet business priorities.

  • Identify project deliverables and contribute to developing project schedules.

  • Ensure proper filing and organization of all documents and correspondence supporting market protection regulatory assessments.

  • Work independently with minimal guidance.

  • Act as a resource for less experienced colleagues.

  • Solve complex problems using new perspectives and existing solutions, exercising judgment based on multiple information sources and maintaining a continuous improvement mindset.

  • Review and approve change orders for anticipated manufacturing, facility, product, and packaging changes in the Product Lifecycle Management Software.

  • Serve as a business partner for manufacturing, operations, and supply chain to advise on the regulatory impact of product and facility changes.

Requirements:

  • Bachelor’s degree with 5+ years of related work experience OR Master’s degree with 3+ years of related work experience.

  • Understanding of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products.

  • Knowledge of US-IVD, CE-IVDD, CE-IVDR governance for IVD diagnostic products.

  • Familiarity with QMS, ISO standards, including ISO 13485.

Preferred Requirements:

  • Prior knowledge of Agile PLM system, SAP ERP system, and Salesforce-based applications.

  • Experience in project management.

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.

Job Tags

Holiday work, Contract work, Temporary work, Work experience placement, Local area, Remote job, Shift work,

Similar Jobs

Jimmy John's

Delivery Drivers!!! HAVE FUN!!! MAKE CASH!! Job at Jimmy John's

 ...DO YOU WANT TO MAKE THAT MONEY??!!!! Jimmy John's Delivery Driver's goal is to get that sandwich in the customer's hand as quick as can be...  ...and doing it with a smile can lead to more successful days. Nights & weekends are required Requirements: Must be at least... 

Night and Day Logistics

Drivers - Independent Courier Job at Night and Day Logistics

Job Description Salary: Up to $1300 IAD Independent Drivers Wanted - Large SUVs/Cargo Van/Minivan only Other hiring locations: Washington, Baltimore Salary: up to $1,300.00 per week REQUIREMENTS:~ Owned/Leased Vehicle ~ Valid Driver's License ~ Valid...

Altus Group

Analyst real property tax Job at Altus Group

 ...our employees drive impact, innovate, and shape the global commercial real estate (CRE) and PropTech industry. Our people-centric...  ...South Lake, TX office. Reporting to the Senior Director, this entry-level role offers a fantastic opportunity to support our... 

A2Zxperts

Database Administrator DBA - PeopleSoftDatabase Administrator Systems Administrator Job at A2Zxperts

 ...c2c/1099 Job titleDatabase Administrator DBA PeopleSoft:Database Administrator Systems Administrator Job locationJacksonMS Job typeContract remote/onsite Experience15 years Required Ss/Experience REQUIRED SS/EXPERIENCE... 

Vero Networks

Business Operations Analyst Job at Vero Networks

 ...The Business Operations Analyst will ensure the efficiency and effectiveness of multiple business facets by conducting financial validations, driving operational improvements, and optimizing processes. The Bus Operations Analyst will have a lens into all business...