Medtronic
Senior Regulatory Affairs Specialist -CAS
Medtronic, Minneapolis, Minnesota, United States, 55400
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.
A Day in the LifeAt 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.
The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Cardiac Ablation Solution devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.
Role and Responsibilities:
Author and prepare regulatory submissions for new products and their product changes as required to ensure timely approval for market release. Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
Negotiate with regulatory agencies, as needed. All significant issues will be reviewed with the supervisor.
Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
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. Independently determines and develops approach.
Frequent inter-organizational contact and some external contacts.
Keeps current on global directives, regulations harmonized standards and Medtronic procedures and communicates changes that may affect cross functional areas.
Provide training and support to other members of the department.
Other tasks, as required.
Must HaveTo be considered for this role, please ensure the minimum requirements are evident in your applicant profile
Bachelor’s degree in a technical discipline
Minimum 4 years of medical device regulatory experience with Bachelor’s degree
Or minimum 2 years of medical device regulatory experience with an advanced degree
Nice To Have
Experience working in 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
In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
History of successful device submissions
Strong negotiation skills and written/oral communication skills
Strong organizational skills and time management skills
Ability to support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Computer skills; MS Office, MS Project, Adobe Acrobat and Agile
Physical Job RequirementsThe 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.
Benefits & CompensationMedtronic 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): $88,800.00 - $133,200.00. 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).
About MedtronicWe 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 90,000+ 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.
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, most positions are posted on our career site for 3-7 days.
#J-18808-Ljbffr
A Day in the LifeAt 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.
The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Cardiac Ablation Solution devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.
Role and Responsibilities:
Author and prepare regulatory submissions for new products and their product changes as required to ensure timely approval for market release. Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
Negotiate with regulatory agencies, as needed. All significant issues will be reviewed with the supervisor.
Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
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. Independently determines and develops approach.
Frequent inter-organizational contact and some external contacts.
Keeps current on global directives, regulations harmonized standards and Medtronic procedures and communicates changes that may affect cross functional areas.
Provide training and support to other members of the department.
Other tasks, as required.
Must HaveTo be considered for this role, please ensure the minimum requirements are evident in your applicant profile
Bachelor’s degree in a technical discipline
Minimum 4 years of medical device regulatory experience with Bachelor’s degree
Or minimum 2 years of medical device regulatory experience with an advanced degree
Nice To Have
Experience working in 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
In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
History of successful device submissions
Strong negotiation skills and written/oral communication skills
Strong organizational skills and time management skills
Ability to support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Computer skills; MS Office, MS Project, Adobe Acrobat and Agile
Physical Job RequirementsThe 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.
Benefits & CompensationMedtronic 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): $88,800.00 - $133,200.00. 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).
About MedtronicWe 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 90,000+ 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.
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, most positions are posted on our career site for 3-7 days.
#J-18808-Ljbffr