国际设备法规事务高级经理
Sr Manager, International Device Regulatory Affairs
**关于该职位：**
作为国际设备法规事务高级经理，您将领导美国以外高风险植入式医疗设备的法规策略和执行工作，重点针对日本、中国和拉丁美洲。您的职责包括制定和管理各国特定的法规计划、提交内容以及生命周期维护活动，以确保及时上市并持续合规。
作为法规代表，您将与国际监管机构、当地代表和区域业务合作伙伴进行沟通，战略性地应对他们的询问和请求。与质量、临床、医学安全和全球法规同事等跨职能团队合作，您将把国际法规要求整合到产品开发和商业化策略中。您的领导力将在推动法规卓越和合规方面发挥关键作用，从而对百健的国际业务目标做出重大贡献。
**您将负责：**
- 领导针对日本、中国和拉丁美洲的高风险植入式医疗设备项目的国际法规策略。
- 作为与国际监管机构和认证机构互动的法规负责人。
- 为产品开发、设计变更和上市后监测提供法规领导。
- 与跨职能团队合作，将各国特定要求转化为可执行的项目计划。
- 监测和评估不断变化的国际医疗器械法规，并推动法规情报的实施。
- 指导法规人员和跨职能团队，支持检查准备和领导层沟通。
- 管理非美国市场的提交和缺陷响应活动。
- 确保符合国际医疗器械营销法规。
- 在日常卫生主管部门互动中代表设备法规事务部门。
**您具备：**
您具有战略思维和对国际法规框架的深入理解，特别是针对高风险植入式医疗器械。您能够有效应对复杂的法规环境并与国际监管机构进行有效沟通，同时具备良好的协作精神。您注重细节，致力于卓越，能够在跨职能环境中茁壮成长，推动合规和创新。
查看英文原文
**About This Role:**
As the Senior Manager of International Device Regulatory Affairs, you will lead regulatory strategies and execution for high-risk implantable medical device submissions beyond the United States, focusing on Japan, China, and Latin America. Your role encompasses developing and managing country-specific regulatory plans, submission content, and lifecycle maintenance activities to ensure timely market access and ongoing compliance.
Serving as the regulatory representative, you'll engage with international regulators, in-country representatives, and regional business partners, aligning strategically with their inquiries and requests. Collaborating cross-functionally with departments such as Quality, Clinical, Medical Safety, and global regulatory colleagues, you will integrate international regulatory requirements into product development and commercialization strategies. Your leadership will be instrumental in driving regulatory excellence and compliance, thereby contributing significantly to Biogen’s international business objectives.
**What You’ll Do:**
- Lead international regulatory strategy for high-risk implantable medical device programs, focusing on Japan, China, and Latin America.
- Serve as the regulatory lead for interactions with international regulators and certification bodies.
- Provide regulatory leadership for product development, design changes, and post-market surveillance.
- Collaborate with cross-functional teams to translate country-specific requirements into actionable program plans.
- Monitor and assess evolving international medical device regulations and drive implementation of regulatory intelligence.
- Mentor regulatory staff and cross-functional teams, supporting inspection readiness and leadership communication.
- Manage coordination of ex-US submission and deficiency response activities.
- Ensure compliance with international medical device marketing regulations.
- Represent Device Regulatory Affairs in routine health authority interactions.
**Who You Are:**
You possess a strategic mindset and a deep understanding of international regulatory frameworks, particularly for high-risk implantable medical devices. Your ability to navigate complex regulatory environments and engage effectively with international regulators is complemented by your collaborative spirit. With a keen eye for detail and a commitment to excellence, you thrive in cross-functional settings, driving compliance and innovation. Your leadership inspires others, and you approach challenges with resilience and adaptability.
**Required Skills:**
- Bachelor’s degree; advanced degree preferred
- 7+ years of Regulatory Affairs experience in Class III implantable medical devices.
- At least 5 years of experience with combination product implantable medical devices.
- Strong understanding of international medical device regulations, especially in Japan, China, and Latin America.
- Experience with cross-functional collaboration in a global setting.
- Proficiency in managing regulatory strategies and submissions for complex medical devices.
- Proven leadership and mentorship capabilities.
- Excellent communication and negotiation skills.
Job Level: Management
**Additional Information**
The base compensation range for this role is: $138,000.00-$184,500.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families _physical, financial, emotional,_ and _social well-being_; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
**Why Biogen?**
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. [Read on](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&data=05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&reserved=0) to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.