Job details

Global Regulatory Affairs Senior Specialist

Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. 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.Position title: Regulatory Affairs Senior Specialist, Global Market ProtectionWorkplace: RemoteShift: M-F, standard working hoursPay rate: $47-$50/hourPosition type: 1 year contract roleOverviewThe 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.Qualifications• 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• Prior knowledge of Agile PLM system, SAP ERP system, and Salesforce-based applications.• Experience in project management.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.#P19611035

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What You Should Know About Global Regulatory Affairs Senior Specialist, Kelly Services

If you're an experienced Regulatory Affairs Senior Specialist looking for an exciting opportunity, look no further! Kelly® Science & Clinical is on the hunt for a talented individual to join a leading molecular diagnostics company at their Sunnyvale, CA headquarters. This one-year contract role is perfect for someone who thrives in a fast-paced environment and is eager to make a significant impact on product lifecycle management. You'll be the go-to person, serving as the RA lead on various project teams. Your responsibilities will include conducting regulatory reporting assessments and advising on compliance strategies while liaising with global regulatory bodies during audits. Working remotely provides you with the flexibility to balance your career ambitions with personal commitments. If you hold a Bachelor's or Master's degree, paired with experience in regulatory affairs, US-IVD, and quality management systems, this could be your perfect next step. At this company, you’ll collaborate with cross-functional teams to implement changes that protect the market, working independently with minimal guidance. Plus, you’ll have the chance to mentor less experienced colleagues, using innovative problem-solving skills to address complex challenges as they arise. Flex your expertise in a role that values continuous improvement and collaboration, and take the leap towards a rewarding career with us!

Frequently Asked Questions (FAQs) for Global Regulatory Affairs Senior Specialist Role at Kelly Services

What are the primary responsibilities of a Global Regulatory Affairs Senior Specialist at Kelly® Science & Clinical?

As a Global Regulatory Affairs Senior Specialist at Kelly® Science & Clinical, your main responsibilities will include leading product lifecycle management project teams, conducting regulatory reporting assessments, and advising on compliance strategies. You will also oversee QMS and compliance activities, ensuring that all documentation related to market protection regulatory assessments is properly organized and filed.