Philips International
Senior Regulatory Affairs Specialist
Philips International, Cambridge, Massachusetts, us, 02140
Senior Regulatory Affairs Specialist page is loaded## Senior Regulatory Affairs Specialistlocations:
Murrysvilletime type:
Full timeposted on:
Posted 9 Days Agojob requisition id:
566015### Job TitleSenior Regulatory Affairs Specialist### Job Description**Senior Regulatory Affairs Specialist****In this role you**The Senior Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.
This may include ventilators, oxygenators, and other accessories.
The role will provide day-to-day regulatory support for new product development and sustaining activities including but not limited to change order support, regulatory planning, and other activities as directed by management.**Your role:*** The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW* Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.* Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process.* Support activities required to maintain regulatory compliance as new or revised versions of standards and guidance documents are published.* Monitor global regulatory landscapes and support implementation of regulation changes and executes quality plans to minimize business impact. Provides Regulatory assessment of product changes for launch and sustaining activities.**You're the right fit if:*** Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.* 5+ years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent OR 2+ years' experience with Master's Degree* Experience with Regulatory Requirements - 21 CFR 820, EU MDR, ISO 13485, Regulatory Standards, Regulatory Submission Documentation - 510k, Health Canada licenses, EU MDR Technical Documentations, Product Registrations - US, EU, Canada, Product Labeling - US, EU, Canada* Preferred Skills**:** Regulatory Requirements,Quality Management Systems (QMS),Troubleshooting,KPI Monitoring and Reporting,Data Analysis & Interpretation,Process Improvements* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.**How we work together**We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.This is an office role.**About Philips**We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.* Learn more about .* Discover* Learn more about* Learn more about**Philips Transparency Details**The pay range for this position in Murrysville, PA is $100,040 to $127,400 Annually.The pay range for this position in Cambridge, MA is $109,100 to $135,000 Annually.The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.
Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
Details about our benefits can be found .At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.**Additional Information**US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits **will not** be provided for this position.
For this position, you must reside in **or** within commuting distance to Murrysville, PA or Cambridge, MA.#LI-PHIThis requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.
Interested candidates are encouraged to apply as soon as possible to ensure consideration.*Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*locations:
3 Locationstime type:
Full timeposted on:
Posted 30+ Days AgoAt Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.*It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.**To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.**Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.* #J-18808-Ljbffr
Murrysvilletime type:
Full timeposted on:
Posted 9 Days Agojob requisition id:
566015### Job TitleSenior Regulatory Affairs Specialist### Job Description**Senior Regulatory Affairs Specialist****In this role you**The Senior Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.
This may include ventilators, oxygenators, and other accessories.
The role will provide day-to-day regulatory support for new product development and sustaining activities including but not limited to change order support, regulatory planning, and other activities as directed by management.**Your role:*** The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW* Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.* Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process.* Support activities required to maintain regulatory compliance as new or revised versions of standards and guidance documents are published.* Monitor global regulatory landscapes and support implementation of regulation changes and executes quality plans to minimize business impact. Provides Regulatory assessment of product changes for launch and sustaining activities.**You're the right fit if:*** Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.* 5+ years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent OR 2+ years' experience with Master's Degree* Experience with Regulatory Requirements - 21 CFR 820, EU MDR, ISO 13485, Regulatory Standards, Regulatory Submission Documentation - 510k, Health Canada licenses, EU MDR Technical Documentations, Product Registrations - US, EU, Canada, Product Labeling - US, EU, Canada* Preferred Skills**:** Regulatory Requirements,Quality Management Systems (QMS),Troubleshooting,KPI Monitoring and Reporting,Data Analysis & Interpretation,Process Improvements* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.**How we work together**We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.This is an office role.**About Philips**We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.* Learn more about .* Discover* Learn more about* Learn more about**Philips Transparency Details**The pay range for this position in Murrysville, PA is $100,040 to $127,400 Annually.The pay range for this position in Cambridge, MA is $109,100 to $135,000 Annually.The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.
Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
Details about our benefits can be found .At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.**Additional Information**US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits **will not** be provided for this position.
For this position, you must reside in **or** within commuting distance to Murrysville, PA or Cambridge, MA.#LI-PHIThis requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.
Interested candidates are encouraged to apply as soon as possible to ensure consideration.*Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*locations:
3 Locationstime type:
Full timeposted on:
Posted 30+ Days AgoAt Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.*It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.**To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.**Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.* #J-18808-Ljbffr