Associate Regulatory Affairs Specialist
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Job Location:
Mounds View, MN - USA
Monthly Salary:
$ 60000 - 90000
Posted on:
7 days ago
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Join the Medtronic Cardiac Ablation Solutions (CAS) regulatory affairs team of innovators who bring their worldview unique backgrounds and individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners and we believe that this drives healthcare forward and sets us apart as a global leader in medical technology and solutions. Cardiac Ablation Solutions is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care cardiac mapping and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias to date CAS has transformed the lives of over 1 million patients.At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were 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
TheAssociate Regulatory Affairs Specialistwill work under the guidance of their manager and more senior regulatory specialists to provide support for Cardiac Ablation Solutions products. This role will include a blend of international regulatory affairs operations and project coordination work. Regulatory affairs work will focus on international submission activities including maintaining regulatory approvals renewals registrations and tender activities and assessment of device changes for registration implications. Regulatory operations work will involve supporting regulatory systems relating to product release economic operator verification registration and listing data management and initiatives to maintain integrity of CAS regulatory information among other activities.
Roles and Responsibilities
Understanding global regulatory requirements and how to research detailed requirements.
Contributing to global product registration maintenance including EU MDR Technical Documentation/MDD Technical Files.
Assessing device changes for registration implications and electronically notifying geographies of regulatory changes.
Routing regulatory documents for approvals in electronic systems maintaining approval information and maintaining electronic document collections.
Supporting requests to systems relating to product release economic operator verification and registration and listing.
Participating in preparation for internal and external regulatory audits.
Compiling materials required for new global product submissions license renewals and change submissions. Monitoring maintaining and improving global regulatory tracking/control systems.
Requesting obtaining and maintaining FDA Certificate of Foreign Government (CFGs) including notarization and legalization EC/ISO certificates and various other regulatory documents.
Keeping abreast of regulatory procedures and changes.
Performing other regulatory duties as needed.
Must Have (Minimum Requirements)
To be considered for this role please ensure the minimum requirements are evident in your applicant profile.
Bachelors degree
0 years of regulatory affairs or related experience
Nice to Have (Preferred Qualifications)
Bachelors Degree in a health profession science and/or engineering field
Experience in medical device industry
Demonstrated technical writing skills
Strong computer skills including word processing spreadsheets and slide presentations
Excellent organizational project management skills
Strong written verbal and interpersonal skills
Notary license
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.
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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
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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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 findhere 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 for employment 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.
Required Experience:
IC
Key Skills
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- IT Support
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
