Medtronic
Overview
We anticipate the application window for this opening will close on - 24 Sep 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Responsibilities
Lead planning and execution of global regulatory activities necessary to obtain and/or maintain regulatory clearance/certification within the United States and Europe for powered surgical devices. Sustain activities including review of all change control activities related to the assigned product family and performing regulatory assessments. Handle LTF, 510(k)s, technical documentation updates, and EU change notices resulting from regulatory assessment. Oversee labeling and ad prom review of the assigned product family. Partner with the international regulatory affairs group to support global submissions and registrations. Support currently marketed products by completing sustaining activities, including evaluating product changes and labeling changes, reviewing ad promo, and submitting change notifications to regulatory authorities. Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for changes to existing products. Collaborate with RAS, engineers, and technical experts to resolve regulatory questions from agencies. Prepare FDA submissions and European Technical Files/Technical Documentation (MDD and MDR) for product changes and/or new products to ensure timely product launches. Prepare submissions and reports for FDA and notifi ed bodies, and support other international agencies as required. Interact with FDA and notified bodies as needed; significant issues reviewed with the manager. Maintain proficiency in US and EU regulatory requirements and establish good relationships with agency personnel. Ensure understanding of quality policy/system items personally applicable; follow all work/quality procedures to ensure quality system compliance and high-quality work. Support post-market regulatory compliance activities for US and EU; keep abreast of regulatory procedures and changes. Develop and maintain regulatory affairs department procedures and implement process improvements. Comply with applicable US, EU, and international regulatory laws/regulations/standards and the Code of Conduct; assist in keeping the company informed of US and EU regulatory requirements. Direct or perform coordination and preparation of document packages for internal audits and inspections; lead or compile materials for submissions, license renewals, and annual registrations. Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections; lead or compile materials for submissions, license renewals, and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance; monitor and improve tracking/control systems. May direct interaction with regulatory agencies on defined matters; recommend strategies for earliest possible approvals of clinical trials applications. Must Have: Minimum Requirements
Bachelor’s degree required Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience Nice to Have
4+ years of U.S. and EU regulatory submission experience (510(k) and Technical Documentation) Experience with software and electrical regulatory requirements. Experience with international standards (ISO, GHTF, ICH, IEC). Proficient understanding of FDA and MDR requirements. Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13483) Experience working with cross-functional teams. Project management skills. Product development experience. Knowledge of Medtronic procedures and systems. Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment. Strong oral and written communication skills. Effective interpersonal skills. Effective team member. Ability to comprehend principles of engineering, physiology, and medical device use. Good analytical skills. Ability to effectively manage multiple projects and priorities. Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint. Experience with Agile. Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $92,000.00 - $138,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. 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). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. 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 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. Medtronic will consider qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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We anticipate the application window for this opening will close on - 24 Sep 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Responsibilities
Lead planning and execution of global regulatory activities necessary to obtain and/or maintain regulatory clearance/certification within the United States and Europe for powered surgical devices. Sustain activities including review of all change control activities related to the assigned product family and performing regulatory assessments. Handle LTF, 510(k)s, technical documentation updates, and EU change notices resulting from regulatory assessment. Oversee labeling and ad prom review of the assigned product family. Partner with the international regulatory affairs group to support global submissions and registrations. Support currently marketed products by completing sustaining activities, including evaluating product changes and labeling changes, reviewing ad promo, and submitting change notifications to regulatory authorities. Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for changes to existing products. Collaborate with RAS, engineers, and technical experts to resolve regulatory questions from agencies. Prepare FDA submissions and European Technical Files/Technical Documentation (MDD and MDR) for product changes and/or new products to ensure timely product launches. Prepare submissions and reports for FDA and notifi ed bodies, and support other international agencies as required. Interact with FDA and notified bodies as needed; significant issues reviewed with the manager. Maintain proficiency in US and EU regulatory requirements and establish good relationships with agency personnel. Ensure understanding of quality policy/system items personally applicable; follow all work/quality procedures to ensure quality system compliance and high-quality work. Support post-market regulatory compliance activities for US and EU; keep abreast of regulatory procedures and changes. Develop and maintain regulatory affairs department procedures and implement process improvements. Comply with applicable US, EU, and international regulatory laws/regulations/standards and the Code of Conduct; assist in keeping the company informed of US and EU regulatory requirements. Direct or perform coordination and preparation of document packages for internal audits and inspections; lead or compile materials for submissions, license renewals, and annual registrations. Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections; lead or compile materials for submissions, license renewals, and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance; monitor and improve tracking/control systems. May direct interaction with regulatory agencies on defined matters; recommend strategies for earliest possible approvals of clinical trials applications. Must Have: Minimum Requirements
Bachelor’s degree required Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience Nice to Have
4+ years of U.S. and EU regulatory submission experience (510(k) and Technical Documentation) Experience with software and electrical regulatory requirements. Experience with international standards (ISO, GHTF, ICH, IEC). Proficient understanding of FDA and MDR requirements. Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13483) Experience working with cross-functional teams. Project management skills. Product development experience. Knowledge of Medtronic procedures and systems. Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment. Strong oral and written communication skills. Effective interpersonal skills. Effective team member. Ability to comprehend principles of engineering, physiology, and medical device use. Good analytical skills. Ability to effectively manage multiple projects and priorities. Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint. Experience with Agile. Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $92,000.00 - $138,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. 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). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. 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 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. Medtronic will consider qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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