Medtronic Plc
Regulatory Affairs Specialist -Cardiac Ablation Solutions
Medtronic Plc, Saint Paul, Minnesota, United States, 55112
Job Title: Regulatory Affairs Specialist
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. At Medtronic Cardiac Ablation Solutions, our vision is to provide cardiac mapping and ablation solutions that will enable clinicians to treat patients more safely and efficiently, with more predictable procedure times and outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. The Regulatory Affairs Specialist helps develop and execute regulatory activities for product registration with global regulatory agencies to introduce Cardiac Ablation Solution devices to market, provide advice on regulatory requirements, support the preparation of worldwide submissions and negotiate their approval as needed. The Specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations to ensure compliance with required global regulations and Medtronic policies. This individual will also serve as a team member of as a lead role on extended team(s). Role and Responsibilities: Provide regulatory support for currently marketed products globally. This includes supporting submissions in the US, EU and rest of the world based on business needs. Act as a regulatory resource in reviewing changes to existing devices and documentation. Assist in the preparation and gradually take lead in authoring submissions and reports for regulatory agencies as required. Review regulatory issues with supervisor, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed. Provide on-going support to project teams for regulatory issues and questions. Apply regulations, SOP and guidance appropriately for situations. Assist in gathering business and product information to support the development of strategies and requirements, as well as communicate that information to the Project teams. Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines. Assist, as required, in gathering information to support regulatory topics and support discussion with regulatory agency in partnership with experienced RAS, cross functional team members and supervisor. Attend and provide regulatory input in project team meeting, including reviewing changes and reviewing technical documentation to ensure compliance to regulatory and Medtronic requirements. Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Cardiac Ablation Solution portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory requirements. Work under general supervision following established procedures. Understands when to escalate matters and gain alignment with manager on work directions and regulatory strategies to determine and develop approach. Coordinate and lead as needed inter-organizational contact and some external contacts. Keeps current on global directives, regulations harmonized standards and Medtronic procedures and communicates any changes that may affect cross functional areas. Other tasks, as required. Must Have; Minimum Requirements: To be considered for this role, please ensure the minimum requirements are evident in your applicant profile Bachelor's degree in a technical discipline Minimum 2 years of medical device, engineering, quality or regulatory experience with Bachelor's degree Or 0 years of medical device regulatory experience with an advanced degree Nice To Have: Experience working in a regulated environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, Notified Bodies, NMPA and PMDA etc.), and working with cross-functional project teams. Master of Science Degree Regulatory submission experience including and not limited to 30-day, Annual Report, 510(k). Experience with FDA requirements, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Supporting device submissions Strong organizational skills and time management skills Negotiating and written/oral communication skills Ability to manage multiple projects, adapt for global interactions, prioritize, conduct team meetings, and accountable to meet project deadlines Computer skills; MS Project, Adobe Acrobat and 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. The employee is also required to 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. 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): $73,600.00 - $110,400.00 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. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). 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. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans 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.
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. At Medtronic Cardiac Ablation Solutions, our vision is to provide cardiac mapping and ablation solutions that will enable clinicians to treat patients more safely and efficiently, with more predictable procedure times and outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. The Regulatory Affairs Specialist helps develop and execute regulatory activities for product registration with global regulatory agencies to introduce Cardiac Ablation Solution devices to market, provide advice on regulatory requirements, support the preparation of worldwide submissions and negotiate their approval as needed. The Specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations to ensure compliance with required global regulations and Medtronic policies. This individual will also serve as a team member of as a lead role on extended team(s). Role and Responsibilities: Provide regulatory support for currently marketed products globally. This includes supporting submissions in the US, EU and rest of the world based on business needs. Act as a regulatory resource in reviewing changes to existing devices and documentation. Assist in the preparation and gradually take lead in authoring submissions and reports for regulatory agencies as required. Review regulatory issues with supervisor, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed. Provide on-going support to project teams for regulatory issues and questions. Apply regulations, SOP and guidance appropriately for situations. Assist in gathering business and product information to support the development of strategies and requirements, as well as communicate that information to the Project teams. Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines. Assist, as required, in gathering information to support regulatory topics and support discussion with regulatory agency in partnership with experienced RAS, cross functional team members and supervisor. Attend and provide regulatory input in project team meeting, including reviewing changes and reviewing technical documentation to ensure compliance to regulatory and Medtronic requirements. Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Cardiac Ablation Solution portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory requirements. Work under general supervision following established procedures. Understands when to escalate matters and gain alignment with manager on work directions and regulatory strategies to determine and develop approach. Coordinate and lead as needed inter-organizational contact and some external contacts. Keeps current on global directives, regulations harmonized standards and Medtronic procedures and communicates any changes that may affect cross functional areas. Other tasks, as required. Must Have; Minimum Requirements: To be considered for this role, please ensure the minimum requirements are evident in your applicant profile Bachelor's degree in a technical discipline Minimum 2 years of medical device, engineering, quality or regulatory experience with Bachelor's degree Or 0 years of medical device regulatory experience with an advanced degree Nice To Have: Experience working in a regulated environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, Notified Bodies, NMPA and PMDA etc.), and working with cross-functional project teams. Master of Science Degree Regulatory submission experience including and not limited to 30-day, Annual Report, 510(k). Experience with FDA requirements, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Supporting device submissions Strong organizational skills and time management skills Negotiating and written/oral communication skills Ability to manage multiple projects, adapt for global interactions, prioritize, conduct team meetings, and accountable to meet project deadlines Computer skills; MS Project, Adobe Acrobat and 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. The employee is also required to 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. 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): $73,600.00 - $110,400.00 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. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). 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. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans 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.