cGxPServe
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Regulatory Affairs Manager
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Regulatory Affairs Manager
role at
cGxPServe In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.
Responsibilities
In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
Requirements
BS/MS degree or equivalent experience required. Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR. Superior presentation skills when communicating with all levels of the organization, business partners, and external sources. Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment. Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesResearch Services Referrals increase your chances of interviewing at cGxPServe by 2x Get notified about new Regulatory Affairs Manager jobs in
Boston, MA . Global Regulatory Affairs Chief of StaffGlobal Regulatory Affairs Chief of Staff Boston, MA $208,200.00-$327,140.00 1 month ago Boston, MA $135,000.00-$165,000.00 15 hours ago Associate Director/Director, Regulatory Affairs Greater Boston $136,000.00-$170,000.00 6 days ago Marlborough, MA $113,700.00-$189,400.00 1 week ago Marlborough, MA $156,560.00-$176,130.00 1 week ago Boston, MA $172,521.00-$202,540.00 1 month ago Associate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 1 month ago Greater Boston $172,521.00-$249,862.00 2 weeks ago Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada) Boston, MA $87,892.99-$118,774.78 6 days ago Associate Director, Global Regulatory AffairsSenior Manager, Regulatory Affairs CMC (Hybrid Onsite) Waltham, MA $121,000.00-$230,000.00 2 weeks ago Sr. Regulatory Affairs Specialist (Austin, TX)Manager, External and Regulatory AffairsAssociate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Global Regulatory Affairs Operations and Planning Lead Cambridge, MA $250,000.00-$290,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Regulatory Affairs Manager
role at
cGxPServe 2 days ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
cGxPServe In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.
Responsibilities
In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
Requirements
BS/MS degree or equivalent experience required. Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR. Superior presentation skills when communicating with all levels of the organization, business partners, and external sources. Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment. Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesResearch Services Referrals increase your chances of interviewing at cGxPServe by 2x Get notified about new Regulatory Affairs Manager jobs in
Boston, MA . Global Regulatory Affairs Chief of StaffGlobal Regulatory Affairs Chief of Staff Boston, MA $208,200.00-$327,140.00 1 month ago Boston, MA $135,000.00-$165,000.00 15 hours ago Associate Director/Director, Regulatory Affairs Greater Boston $136,000.00-$170,000.00 6 days ago Marlborough, MA $113,700.00-$189,400.00 1 week ago Marlborough, MA $156,560.00-$176,130.00 1 week ago Boston, MA $172,521.00-$202,540.00 1 month ago Associate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 1 month ago Greater Boston $172,521.00-$249,862.00 2 weeks ago Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada) Boston, MA $87,892.99-$118,774.78 6 days ago Associate Director, Global Regulatory AffairsSenior Manager, Regulatory Affairs CMC (Hybrid Onsite) Waltham, MA $121,000.00-$230,000.00 2 weeks ago Sr. Regulatory Affairs Specialist (Austin, TX)Manager, External and Regulatory AffairsAssociate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Global Regulatory Affairs Operations and Planning Lead Cambridge, MA $250,000.00-$290,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr