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

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. Were working onsite 4 days a week to drive performance foster an environment of belonging and collaborate to inspire as we engineer the extraordinary.This

This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products. The Principal Regulatory Affairs Specialist will exercise a leadership role and serve as a mentor to help develop regulatory depth and knowledge within the regulatory department staff. The Principal Regulatory Affairs Specialist will assist Regulatory Affairs management by overseeing the activities required to maintain products manufactured and/or distributed by Medtronic ENT are in full compliance with U.S. and all applicable international regulatory requirements

• Maintain current knowledge of the development and changes to applicable laws regulations and industry standards and assist in the dissemination of this information to the appropriate individuals within the company.
• Interpret new and existing regulatory requirements as they relate to Medtronic ENT products and initiate actions to assure compliance to these regulations.
• Participate as the regulatory representative on new product development/modification project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release.
• Lead submission activities for devices in gaining required clearances/approvals through the processes of IDEs 510(k)s PMAs CE marking and combination products.
• Review change orders and assess regulatory impact of product changes.
• Review labeling training promotional and advertising material.
• Represent the organization on cross-business and cross-geography working groups to execute objectives of the Regulatory Council.
• Have input to and influence the development of regulatory requirements through work with regulatory bodies industry groups and through coordinated efforts with corporate Medtronic.
• Provide support for acquisitions including due diligence and post-acquisition assessment and education.
• Support the development and implementation of regulatory education and training across the business.
• Assist with the development and implementation of department policies and procedures.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental health and safety related site rules policies or governmental regulations.
• All other duties as assigned.
• Travel requirement: 10-20%

BASIC QUALIFICATIONS:

EDUCATION REQUIRED:

• Bachelors Degree with a minimum of 7 years of relevant experience or an advance degree with a minimum of 5 years of relevant experience

YEARS OF EXPERIENCE

• 7 years with Bachelors Degree medical device experience and work experience in regulatory affairs.
• 5 years with Masters Degree medical device experience and work experience in regulatory affairs.

SPECIALIZED KNOWLEDGE REQUIRED

• Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU.

PREFERRED QUALIFICATIONS

• Bachelors degree in science engineering healthcare or related field.
• 10 years with Bachelors Degree medical device experience and work experience in regulatory affairs.
• 8 years with Masters Degree medical device experience and work experience in regulatory affairs.
• In-depth knowledge of U.S. and EU regulations and a working knowledge of key industry standards applicable to a medical device manufacturer with functional understanding of international device regulations.
• Understanding of medical electrical equipment and their respective regulations.
• Understanding of combination products and their respective regulations.
• Knowledge of Good Manufacturing Practices.
• Knowledgeable in the due-diligence evaluation process of companies and/or product acquisition.
• Excellent written and oral communication skills and good presentation skills.
• Proficiency in MS Word Excel and PowerPoint.
• Excellent organization and multi-project management skills and attention to detail.
• Must have high tolerance to ambiguity.

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.