Regulatory Engineering Program Manager
Apple
Regulatory Engineering Program Manager
Job Description
Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something. Our ever-evolving suite of health and wellness products are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health - strengthening our commitment to leave the world better than we found it. This role supports the launch of regulated health features, directly contributing to our users' healthier lives worldwide. You will build relationships across Apple's diverse teams to support regulatory efforts and enable global feature availability. The Program Manager's responsibilities include providing comprehensive support for regulatory and quality activities in China and the APAC region. This includes product submissions, market initiatives, and policy interactions. - Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the portfolio - Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners - Communicate program status and escalate risks to a variety of stakeholders - Establish and manage Design History File documentation timelines and successful execution across multiple cross-functional stakeholders
Locations
- Beijing, Beijing, China 100045
- Shanghai, Shanghai, China 200335
Salary
Salary not disclosed
Skills Required
- overseeing regulatory submissionsintermediate
- managing launch readinessintermediate
- handling design changesintermediate
- managing medical device policy activitiesintermediate
- establishing understanding of critical pathintermediate
- coordinating activitiesintermediate
- resolving problemsintermediate
- communicating program statusintermediate
- escalating risksintermediate
- establishing and managing Design History File documentation timelinesintermediate
- managing cross-functional stakeholdersintermediate
- building relationships across teamsintermediate
- supporting regulatory effortsintermediate
Required Qualifications
- Bachelor’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 8+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 8 years)
- Proven track record of driving regulatory submissions and quality system implementations with multi-disciplinary teams (experience)
- Outstanding communication and organizational skills. Ability to optimally manage multiple projects simultaneously (experience)
- Excellent analytical and problem-solving capabilities, with a keen eye to detect and mitigate risks (experience)
- Independent self-starter who thrives in ambiguous environments (experience)
- Hands-on experience in the use of project management and reporting software (experience)
- Fluent in Mandarin (experience)
- May require travel (experience)
Preferred Qualifications
- Master’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 10+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 10 years)
- Solid understanding of regulatory process for different classes of medical devices in China and other international jurisdictions (experience)
- Proven track record of driving clinical activities and regulator engagements (experience)
- Experience with implementation of tools and systems for process management (experience)
Responsibilities
- The Program Manager's responsibilities include providing comprehensive support for regulatory and quality activities in China and the APAC region. This includes product submissions, market initiatives, and policy interactions.
- - Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the portfolio
- - Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners
- - Communicate program status and escalate risks to a variety of stakeholders
- - Establish and manage Design History File documentation timelines and successful execution across multiple cross-functional stakeholders
Tags & Categories
Regulatory Engineering Program Manager
Apple
Regulatory Engineering Program Manager
Job Description
Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something. Our ever-evolving suite of health and wellness products are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health - strengthening our commitment to leave the world better than we found it. This role supports the launch of regulated health features, directly contributing to our users' healthier lives worldwide. You will build relationships across Apple's diverse teams to support regulatory efforts and enable global feature availability. The Program Manager's responsibilities include providing comprehensive support for regulatory and quality activities in China and the APAC region. This includes product submissions, market initiatives, and policy interactions. - Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the portfolio - Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners - Communicate program status and escalate risks to a variety of stakeholders - Establish and manage Design History File documentation timelines and successful execution across multiple cross-functional stakeholders
Locations
- Beijing, Beijing, China 100045
- Shanghai, Shanghai, China 200335
Salary
Salary not disclosed
Skills Required
- overseeing regulatory submissionsintermediate
- managing launch readinessintermediate
- handling design changesintermediate
- managing medical device policy activitiesintermediate
- establishing understanding of critical pathintermediate
- coordinating activitiesintermediate
- resolving problemsintermediate
- communicating program statusintermediate
- escalating risksintermediate
- establishing and managing Design History File documentation timelinesintermediate
- managing cross-functional stakeholdersintermediate
- building relationships across teamsintermediate
- supporting regulatory effortsintermediate
Required Qualifications
- Bachelor’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 8+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 8 years)
- Proven track record of driving regulatory submissions and quality system implementations with multi-disciplinary teams (experience)
- Outstanding communication and organizational skills. Ability to optimally manage multiple projects simultaneously (experience)
- Excellent analytical and problem-solving capabilities, with a keen eye to detect and mitigate risks (experience)
- Independent self-starter who thrives in ambiguous environments (experience)
- Hands-on experience in the use of project management and reporting software (experience)
- Fluent in Mandarin (experience)
- May require travel (experience)
Preferred Qualifications
- Master’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 10+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 10 years)
- Solid understanding of regulatory process for different classes of medical devices in China and other international jurisdictions (experience)
- Proven track record of driving clinical activities and regulator engagements (experience)
- Experience with implementation of tools and systems for process management (experience)
Responsibilities
- The Program Manager's responsibilities include providing comprehensive support for regulatory and quality activities in China and the APAC region. This includes product submissions, market initiatives, and policy interactions.
- - Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the portfolio
- - Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners
- - Communicate program status and escalate risks to a variety of stakeholders
- - Establish and manage Design History File documentation timelines and successful execution across multiple cross-functional stakeholders
Tags & Categories