p/>If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find herea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Minneapolis, MN30+ days ago
This role involves: \n\n Providing expert advice on regulatory requirements \n \n\n Preparing submissions \n \n\n Supporting approval activities \n \n\n Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations \n \n\n \nA Day In The Life \n\n Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Please note some of the above benefits may not apply to workers in Puerto Rico.\n \nFurther details are available at the link below:\n \nMedtronic benefits and compensation plans\n \nAbout Medtronic\n \nWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.\n \nOur Mission \u2014 to alleviate pain, restore health, and extend life \u2014 unites a global team of 95,000+ passionate people.
Minneapolis, MN7 days ago
p>The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Saint Paul, Minnesota29 days ago
Bachelors Degree (± 2 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience . This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.
The environment provides exposure to a wide variety of products, regulations, and cross-functional partners, and is well-suited for someone who enjoys problem-solving, structured processes, and working across teams in a professional office setting. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
Minneapolis, MN23 days ago
The role requires strong collaboration with cross‐functional partners and combines regulatory expertise, scientific knowledge, and business acumen to ensure products are developed, manufactured, and maintained in compliance with applicable global regulatory requirements.
Working independently under the direction of Regulatory Affairs Management, this position owns regulatory impact assessments and develops compliant, risk‐based regulatory strategies across product development and lifecycle activities.
We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. Collaborate closely with product development, supply chain, project management, marketing, and sales teams to ensure the global compliance of marketed lubricants.
We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. Collaborate closely with product development, supply chain, project management, marketing, and sales teams to ensure the global compliance of marketed lubricants.
We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. Collaborate closely with product development, supply chain, project management, marketing, and sales teams to ensure the global compliance of marketed lubricants.
Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation. This role involves working with regulatory affairs personnel across 80+ countries who are responsible for registering or re-registering medical devices and pharmaceutical products locally.
p>As an individual contributor, the International Regulatory Affairs Specialist I performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
li>Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
li>Manage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. The Regulatory and Clinical Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements.
New Brighton, MN28 days ago
p>This position serves as the Structural Heart (SH) Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps SH RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process. Actively participate in all Global Regulatory Compliance team meetings and be prepared to summarize and communicate key highlights to the broader team, including project planning, documentation, task completion, updates, and issues requiring resolution.
Saint Paul, Minnesota29 days ago
div>This position serves as the Structural Heart (SH) Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps SH RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.
• Actively participate in all Global Regulatory Compliance team meetings and be prepared to summarize and communicate key highlights to the broader team, including project planning, documentation, task completion, updates, and issues requiring resolution.
Experience: Requires a minimum of three (3) years of progressively responsible experience in healthcare compliance, regulatory oversight, auditing, or survey management, including direct responsibility for interpreting regulations, supporting audits or surveys, reviewing policies for regulatory alignment, and advising operational or clinical leaders on compliance requirements, preferably in senior care settings such as skilled nursing, assisted living, or PACE. •PACE Specialist: Serve as regulatory resource for participant rights, IDT processes, service authorization timeliness, homecare supervisory expectations, contracted provider compliance, grievances/ appeals, and adherence to the PACE three-way agreement.
li>Experience: Requires a minimum of three (3) years of progressively responsible experience in healthcare compliance, regulatory oversight, auditing, or survey management, including direct responsibility for interpreting regulations, supporting audits or surveys, reviewing policies for regulatory alignment, and advising operational or clinical leaders on compliance requirements, preferably in senior care settings such as skilled nursing, assisted living, or PACE. •PACE Specialist: Serve as regulatory resource for participant rights, IDT processes, service authorization timeliness, homecare supervisory expectations, contracted provider compliance, grievances/ appeals, and adherence to the PACE three-way agreement.
ul>Bachelors Degree (± 2 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience.
This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.
Saint Croix, VI8 days ago
Work is performed in accordance with established policies but use of good judgement and independent decision-making is required in the application consulting, enforcement of rules and regulations/licensure laws. An employee in this class is responsible for ensuring compliance and recommending appropriate licensure and certification of childcare facilities.
Assists with ensuring products marketed meet regulatory requirements related to GHS, USMCA, Import/Export regulations, REACH and other regulatory entities as required. With a purpose to make tomorrow a little bit better than today for each other, our customers, and our communities, Ascentek provides an environment where you can love what you do and be your best every day.
Mounds View, MN30+ days ago
This role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Minneapolis, MN5 days ago
li>Lead enterprise-wide engagement with Commercial Operations, Transmission, Integrated System Planning, Operating Companies, Legal, Regulatory, and other internal stakeholders on federal regulatory issues affecting transmission service, wholesale power transactions, organized wholesale market rules and trading strategies, generator interconnections, open access transmission policies, RTO participation, and transmission and wholesale business decisions. Provide strategic leadership and subject matter expertise on federal regulatory, wholesale market, transmission, reliability, tariff, and compliance matters before the Federal Energy Regulatory Commission (FERC), North American Electric Reliability Corporation (NERC), NERC Regional Entities, Regional Transmission Organizations (RTOs), and other regional organizations.
p>The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Mounds View, Minnesota6 days ago
p>If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval.
Arden Hills, MN30+ days ago
p>The Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA) is responsible for leading global regulatory strategy and execution for Boston Scientific's Pulsed Field Ablation portfolio, the company's most strategically critical and fastest-growing segment within Electrophysiology. In this role, you will provide strategic regulatory leadership and serve as the primary regulatory point of contact for PFA strategy, escalations, and program-level decision-making across new products, sustaining activities, global expansion, and compliance initiatives.
Arden Hills, MN30+ days ago
p>The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. • Minimum of 10 years experience in Regulatory Affairs or related compliance experience within the medical device industry and experience directly reviewing advertising, promotional, sales, and training materials for medical devices.