法规事务承包商
Regulatory Affairs Contractor
监管事务合同工将为医疗设备组合和业务整合活动提供监管支持。该职位将与监管事务部门及跨职能合作伙伴紧密合作，支持全球监管规划、产品注册、生命周期管理以及整合相关的监管活动。
理想的候选人应具备实际的医疗设备监管事务经验，并能够在快节奏、跨职能的环境中独立管理多项全球监管交付物。
地点：远程 - 仅限哥伦比亚
公司简介：
Abstra 是一家快速发展的近岸科技人才服务公司，为美国公司及其他地区提供顶级拉丁美洲科技人才。由拥有超过15年经验的美国工程师创立，Abstra 专长于在广泛的技术领域中寻找专业人才，以满足客户的需求，推动创新和效率。
主要职责
- 支持医疗设备产品和组合整合到现有业务流程和系统中的监管活动。
- 制定、更新并维护全球监管计划（GRPs）及相关监管文件。
- 支持全球产品注册、续期、许可证维护及其他特定市场的监管要求。
- 评估产品、制造、标签、供应商、场所和质量体系变更的监管影响。
- 支持法律制造商、制造场所和质量体系转换相关的监管活动，视情况而定。
- 与区域监管事务团队协调，识别国家特定要求，并执行必要的监管行动以保持市场准入。
- 支持欧盟MDR及其他全球监管生命周期活动，包括技术文件更新、评估、提交和通知，视情况而定。
- 审核现有监管文件，识别差距，并协调所需行动以支持整合和持续合规。
- 维护监管跟踪表、计划和交付物，并确保活动按既定时间表完成。
- 与质量、运营、研发、临床、供应链及其他跨职能利益相关者合作，支持整合活动。
- 识别并上报监管风险、依赖关系及对业务或整合时间表的潜在影响。
查看英文原文
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.
Location:Remote - Colombia Only
About the Company:
Abstra is a fast-growing, Nearshore Tech Talent services company, providing top Latin American tech talent to U.S. companies and beyond. Founded by U.S.-bred engineers with over 15 years of experience, Abstra specializes in sourcing skilled professionals across a wide range of technologies to meet our clients’ needs, driving innovation and efficiency.
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, labelling, 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.
Required 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.
What We Offer:
- Competitive compensation paid in USD.
- 20 days of paid time off (PTO) per year.
- Opportunities for professional growth and career development.
- Company-provided equipment.
- A collaborative, inclusive, and multicultural work environment.
- The opportunity to contribute to meaningful projects alongside a talented and supportive team.
Pre-Employment Verification:
As part of our standard onboarding process, candidates who successfully complete the interview process and accept an employment offer will be required to complete an employment verification check, and background check. This process will confirm job titles and dates of employment with two previous employers and is a standard requirement for all new employees joining the company.
Originally posted on Himalayas