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Regulatory Affairs Specialist

LanceSoft, Inc.

Role overview

Qualifications

  • Bachelor’s degree in life sciences, engineering, Regulatory Affairs, or a related discipline.
  • 3–5+ years of medical device Regulatory Affairs experience preferred.
  • Experience with global medical device registrations and lifecycle management.
  • Working knowledge of FDA medical device requirements and EU MDR.

Responsibilities

  • Support regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems.
  • Develop, update, and maintain Global Regulatory Plans (GRPs) and associated regulatory documentation.
  • Support global product registrations, renewals, license maintenance, and other market-specific regulatory requirements.
  • Assess regulatory impact of product, manufacturing, labeling, supplier, site, and quality system changes.

Key facts

Hard skills

Other skills

  • Problem Solving
  • Collaboration

About the company

LanceSoft, Inc. logo

LanceSoft, Inc.

Staffing & Recruiting

Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele. As a Certified MBE and Woman-Owned organization, we pride ourselves on fostering global cross-cultural connections that advance both the careers of our employees and the success of our clients' businesses. At LanceSoft, our mission is clear: to leverage our global network to seamlessly connect businesses with the right talent and individuals with the right opportunities, all without bias. We believe in providing Global Workforce Solutions with a personalized, human touch. Our comprehensive range of services spans various domains, encompassing temporary and permanent staffing, Statement of Work (SOW) arrangements, payrolling, Recruitment Process Outsourcing (RPO), application design and development, program/project management, and engineering solutions. Currently, our team of over 5,000 professionals caters to 110+ enterprise clients worldwide, including Fortune companies. Our client base represents a diverse spectrum of industries, including Banking & Financial Services, Semiconductor/VLSI, Technology, Healthcare & Life Sciences, Government, Telecom & Media, Retail & Distribution, Oil & Gas, and Energy & Utilities. Headquartered in Herndon, VA, LanceSoft operates 32+ regional offices across the North America, Europe, Asia, and Australia. We also have nine delivery centers strategically located in India in Bangalore, Indore, Noida, Baroda, Hyderabad, Bhubaneshwar, Dehradun, Goa, and Aligarh to further enhance our client service capabilities.

Company details

Company typeXLarge
IndustryStaffing & Recruiting
Company size5001 - 10000

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Job description

Title: Regulatory Affairs Contractor
Location: Country of Columbia
Duration: 12 Months

Position Summary
The Regulatory Affairs Contractor will provide regulatory support for medical device portfolio and business integration activities. The role will work closely with Regulatory Affairs and cross-functional partners to support global regulatory planning, product registrations, lifecycle management, and execution of integration-related regulatory activities.
The ideal candidate will have hands-on medical device Regulatory Affairs experience and be comfortable independently managing multiple global regulatory deliverables in a fast-paced, cross-functional environment.

Key Responsibilities
  • Support regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems.
  • Develop, update, and maintain Global Regulatory Plans (GRPs) and associated regulatory documentation.
  • Support global product registrations, renewals, license maintenance, and other market-specific regulatory requirements.
  • Assess regulatory impact of product, manufacturing, labeling, supplier, site, and quality system changes.
  • Support regulatory activities associated with legal manufacturer, manufacturing site, and quality system transitions, as applicable.
  • Coordinate with regional Regulatory Affairs teams to identify country-specific requirements and execute regulatory actions necessary to maintain market access.
  • Support EU MDR and other global regulatory lifecycle activities, including technical documentation updates, assessments, submissions, and notifications, as applicable.
  • Review existing regulatory documentation, identify gaps, and coordinate actions required to support integration and ongoing compliance.
  • Maintain regulatory trackers, plans, and deliverables and ensure activities are completed according to established timelines.
  • Partner with Quality, Operations, R&D, Clinical, Supply Chain, and other cross-functional stakeholders to support integration activities.
  • Identify and escalate regulatory risks, dependencies, and potential impacts to business or integration timelines.

Qualifications
  • Bachelor’s degree in life sciences, engineering, Regulatory Affairs, or a related discipline.
  • 3–5+ years of medical device Regulatory Affairs experience preferred.
  • Experience with global medical device registrations and lifecycle management.
  • Working knowledge of FDA medical device requirements and EU MDR; experience with additional international markets preferred.
  • Experience with regulatory change assessments, global regulatory planning, and/or business or product integration activities preferred.
  • Ability to independently manage multiple regulatory deliverables and collaborate effectively across global teams.
  • Strong organizational, written communication, and problem-solving skills.

Preferred Experience
Experience with Class II/III medical devices, global regulatory plans, EU MDR, regulatory change assessments, and integration or transition of established medical device portfolios is highly desirable.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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