法规事务经理（美国总部，--，美国，NA）
Regulatory Affairs Manager (USA Home Office, --, US, NA)
Requistion ID: 83800
Dentsply Sirona 是全球最大的专业牙科产品和技术制造商，拥有百年创新和为全球牙科行业及患者服务的经验。Dentsply Sirona 开发、制造并推广全面的解决方案，包括牙科和口腔健康产品以及其他消耗性医疗设备，旗下拥有一系列世界级品牌。
Dentsply Sirona 的产品提供创新、高质量且有效的解决方案，以提升患者护理水平并提供更安全的牙科护理。Dentsply Sirona 总部位于北卡罗来纳州夏洛特市。公司股票在美国纳斯达克交易所上市，代码为 XRAY。了解更多关于 Dentsply Sirona 及其产品的信息，请访问官网。
该职位可远程办公。候选人必须位于美国，最好是东部时间区。
职位概述：
监管事务经理的主要职责是监督 Dentsply Sirona 植入物和修复产品团队的日常运作。该职位负责现有、新开发及修改后的医疗器械和其他（受监管）产品的监管策略制定。该职位负责提交 510(k) 文件，并管理与 FDA 的沟通，包括预提交。该职位还需对其直属下属以及跨职能产品开发团队在美欧监管要求方面进行指导和提供支持。
该职位与业务合作伙伴紧密合作，确保各自国家的注册合规，并作为推动改善业务系统和合规性的内部倡导者。
主要职责：
- 制定并实施监管策略，以获得并维持医疗器械和其他受监管产品的全球监管批准。
- 领导并管理监管提交工作，包括 510(k) 提交和 CE 标志的技术文件。
- 代表公司与 FDA 和欧盟公告机构进行沟通，包括 FDA 预提交、FDA 510(k) 提交和欧盟技术文件提交。
- 在产品生命周期内为跨职能团队提供监管指导和支持。审查并解读监管要求和指南文件，以确保合规。
- 协调内部团队和外部监管机构的监管活动。
查看英文原文
Requistion ID: 83800
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.
Dentsply Sirona’s products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit for more information about Dentsply Sirona and its products.
This position can be a remote working arrangement. Candidates must be located in the US, ideally in the eastern time zone.
Job Summary:
The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
- Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
- Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
- Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
- Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
- Coordinates regulatory activities with internal teams and external regulatory agencies.
- Reviews and approves product labelling and claims for the US and EU markets.
- Stays current with regulatory requirements and updates affected policies and procedures.
- Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
- Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
- Complies with company and departmental policies and administrative requirements.
- Performs other duties as assigned or as needed.
Education:
- Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
- Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master’s degree in a scientific discipline is a plus.
Years and Type of Experience:
- 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
- Experience with leading regulatory submissions and managing regulatory projects.
- In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
- Experience with software as a medical device, AI and/or medical devices containing software is a plus
Required Computer / Software Skills:
- Proficiency with Microsoft Office Suite
- Proficiency with Regulatory software
Key Required Skills, Knowledge, and Capabilities:
- Strong leadership, project management, and organizational skills including attention to detail.
- Strong written and verbal communication skills.
- Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
- Excellent interpersonal skills.
- Ability to work effectively in a team environment and independently.
- Knowledge of regulatory affairs principles and practices.
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
- Willingness to learn and adapt to new processes and technologies.
- Leadership experience within medical device organizations.
Key Leadership Behaviors:
- Actively articulates and promotes Dentsply Sirona’s vision and direction.
- Advocates on behalf of the customer.
- Values driven with an insistence on excellence.
- Promotes high performance, innovation, and continual improvement.
- Consistently meets Company standards, ethics, and compliance requirements.
- Strong results orientation and analytical skills.
- Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
- Resolves conflicts and fosters a positive working environment.
The base salary and target annual incentive for this remote role is between $154,000 - $165,000. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.
Eligibility: All successful applicants must be eligible to work in the country the position is based.
Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to .
Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.
Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: .
Originally posted on Himalayas