Regulatory Affairs Manager, Asia-pacific

As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator® Synergy Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients’ worldwide.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

***:
The Asia-Pacific (APAC) Regulatory Affairs Manager provides oversight of regulatory submissions to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will prepare and submit submissions to regulatory authorities, which may include China, Japan, Korea, Taiwan, Malaysia, and other APAC geographies,to support business growth. The position will serve as regulatory representative for the Asia Pacific region for monitoring regulations changes and formulating regulatory strategies for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals.

**ESSENTIAL FUNCTIONS OF THE POSITION**:

- Oversee the APAC regulatory submission process with 3rd party regulatory service providers and distributors; oversee the authorship and publication of electronic submissions.
- Manage the development of dossiers for registration of products in countries in the APAC region
- Develop and communicate regulatory strategy for new products by working with the regional and global commercial teams.
- Track and monitor regulatory submissions in APAC markets based on commercial prioritization and business plans
- Keep all areas of AtriCure informed of regulatory requirements and emerging issues which may affect the registration approval of products in the countries of responsibility.
- Build and maintain effective relationship with authorities and associations
- Shape regulations and standards to create favorable regulatory environment to the business
- Liaise with Regulatory Authorities in regulatory submissions, proposals, analysis and submission of change notifications and provide timely response to input requests
- Responsible for regulatory plan for new products, including clinical study compliance and submission requirements.
- Monitor regulatory updates and create actions plans to address relevant regulations with alignment among internal and external stakeholders
- Organize Regulatory Committee monthly meeting with APAC Sales and Marketing Teams and follow up agreed actions to ensure timely support to business focuses
- Communicate with Regulatory agencies.
- Responsible for oversight and prioritization of departmental tasks and projects.
- Lead compliance related projects to ensure our company meets legislative requirements

**ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION**:

- Regular and predictable worksite attendance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned

**BASIC QUALIFICATIONS**:

- Bachelor’s degree required or demonstrated equivalent combination of education, training and experience
- A minimum of 7 years of regulatory affairs working experience, mainly for medical devices.
- Must have working knowledge of APAC medical device regulations and standards
- Experience in preparing regulatory submissions; Experience interacting with NMPA, PMDA, MFDS and/or other regulatory agencies
- Business proficiency in spoken and written English and Mandarin
- Ability to work and collaborate with both internal and external stakeholders.
- Ability to manage multiple projects and registrations
- Must demonstrate good technical writing skills and demonstrate good communication skill in team setting
- Strong computer skills
- Ability to travel 20-25%

**PREFERRED QUALIFICATIONS**:

- 4-year degree in a technical/scientific discipline
- Working experience with APAC regulatory agencies with cardiovascular devices.