Senior Regulatory Affairs Specialist, Global Market Expansion

Kelly; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

An innovative firm is seeking a Senior Regulatory Affairs Specialist for a one-year remote contract. This role involves leading regulatory assessments, advising on compliance strategies, and collaborating with cross-functional teams to ensure adherence to global regulations. The ideal candidate will possess a strong background in Regulatory Affairs, with experience in IVD products and project management. Join a dynamic team and contribute to advancements in biotechnology and diagnostics while enjoying the flexibility of a remote work environment.

Qualifications

• 5+ years of experience in Regulatory Affairs or related fields.
• Understanding of IVD diagnostic product regulations.

Responsibilities

• Lead product lifecycle management project teams.
• Advise on regulatory impacts and compliance strategies.

Skills

Regulatory Affairs

Project Management

Problem Solving

Communication

Education

Bachelor's Degree

Master's Degree

Tools

Agile PLM

SAP ERP

Salesforce

Job description

Senior Regulatory Affairs Specialist, Global Market Expansion

This range is provided by Kelly. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$47.00/hr - $50.00/hr

Direct message the job poster from Kelly

Senior Recruiter | PhD-level Scientist | Working Parent | Immigrant | Helping scientists answer the question of what's next?

Kelly Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a one-year contract remote 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 and molecular diagnostics industries.

Position title: Regulatory Affairs Senior Specialist, Global Market Protection

Workplace: Remote

Pay rate: $47-$50/hour

Position type: one-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.

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.

Seniority level

• Associate

Employment type

• Contract

Job function

• Analyst, Quality Assurance, and Science