Philips
Regulatory Affairs Program Manager
Philips, San Diego, California, United States, 92189
Job Title:
Regulatory Affairs Program ManagerJob Description:The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips’ Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes.Your role:Provide Regulatory technical expertise (tactical and strategic), including accurate and consistent regulatory recommendations, decisions, and feedback to product development/manufacturing teams and preparing comprehensive regulatory strategies for new devices/significant post market changes.Create detailed written regulatory plans that can be used to support international regulatory submissions and global product sales and develop/prepare product registration submissions for the US, Canada, EU, and support submission preparation for all regulated markets.Perform regulatory impact and regulatory compliance evaluations to support engineering changes and post market activities. Review and approve advertising, promotional items, and labeling for regulatory compliance.Identify potential regulatory approvals' risks based on changes in regulations, standards, country-specific issues, or other unique characteristics of the project.Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations and drive regulatory improvements of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.Reporting to the Head of Regulatory Affairs for AM&D, you will partner with Internal Stakeholders and collaborate with worldwide colleagues regarding license renewals and updates.You're the right fit if:You have a minimum of 7 years’ experience in FDA Regulated Medical Device environments, with a focus on the preparation/submission of 510K’s, PMA’s and experience with EU MDR/MDD, Health Canada, China, etc.You’re experienced in supporting international registrations and/or clinical investigations and proficient in Microsoft Office.You have a strong background in Design Controls and detailed knowledge of global medical device regulations/laws/standards including: (21CFR), FDA law, MDD/MDR, ISO 14971, IEC 60601-1, and related particular standards.You have a proven understanding of LEAN concepts, methodologies, and deployment.You have a minimum of a Bachelor’s degree (REQUIRED) in Regulatory Affairs and/or a science or engineering related field. Master’s/PhD desired.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.Philips Transparency Details:The pay range for this position in Eagan, MN is $105,000 to $178,000.The pay range for this position in Malvern, PA or Chicago, IL is $109,000 to $187,000.The pay range for this position in Cambridge, MA is $116,000 to $200,000.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.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 Eagan, MN, Malvern, PA, Chicago, IL or Cambridge, MA.#LI-PH1This 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/Disabled/Veteran and maintains a drug-free workplace.
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Regulatory Affairs Program ManagerJob Description:The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips’ Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes.Your role:Provide Regulatory technical expertise (tactical and strategic), including accurate and consistent regulatory recommendations, decisions, and feedback to product development/manufacturing teams and preparing comprehensive regulatory strategies for new devices/significant post market changes.Create detailed written regulatory plans that can be used to support international regulatory submissions and global product sales and develop/prepare product registration submissions for the US, Canada, EU, and support submission preparation for all regulated markets.Perform regulatory impact and regulatory compliance evaluations to support engineering changes and post market activities. Review and approve advertising, promotional items, and labeling for regulatory compliance.Identify potential regulatory approvals' risks based on changes in regulations, standards, country-specific issues, or other unique characteristics of the project.Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations and drive regulatory improvements of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.Reporting to the Head of Regulatory Affairs for AM&D, you will partner with Internal Stakeholders and collaborate with worldwide colleagues regarding license renewals and updates.You're the right fit if:You have a minimum of 7 years’ experience in FDA Regulated Medical Device environments, with a focus on the preparation/submission of 510K’s, PMA’s and experience with EU MDR/MDD, Health Canada, China, etc.You’re experienced in supporting international registrations and/or clinical investigations and proficient in Microsoft Office.You have a strong background in Design Controls and detailed knowledge of global medical device regulations/laws/standards including: (21CFR), FDA law, MDD/MDR, ISO 14971, IEC 60601-1, and related particular standards.You have a proven understanding of LEAN concepts, methodologies, and deployment.You have a minimum of a Bachelor’s degree (REQUIRED) in Regulatory Affairs and/or a science or engineering related field. Master’s/PhD desired.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.Philips Transparency Details:The pay range for this position in Eagan, MN is $105,000 to $178,000.The pay range for this position in Malvern, PA or Chicago, IL is $109,000 to $187,000.The pay range for this position in Cambridge, MA is $116,000 to $200,000.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.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 Eagan, MN, Malvern, PA, Chicago, IL or Cambridge, MA.#LI-PH1This 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/Disabled/Veteran and maintains a drug-free workplace.
#J-18808-Ljbffr