Sr Manager - Development Process & Compliance

Careers That Change Lives

The Diabetes Group at Medtronic is part of Medtronic PLC, the global leader in medical technology. We are committed to ongoing breakthrough developments in leading-edge technology, unrivaled service and support, and uncompromising leadership. Medtronic is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care and improving outcomes, so people with diabetes can enjoy greater freedom and better health.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• This position willprovide support and guidance to Program Management Leaders and cross functional team members on navigating through product development activities through the product lifecycle ensuring compliance with regulations and standards.

• This role is critical to ensuring that products meet regulatory requirements and quality standards throughout the design process. In this role you will help mitigate risks, ensure compliance with relevant regulations, and maintain product integrity.

• Proactive individual with expert level understanding of design controls and ability to apply knowledge to influence product development Standard Operating Procedures and provide guidance to Product Innovation leaders.

• Experienced auditing design history files to ensure compliance with regulations and standards.

• Monitor changes in regulations and update internal procedures as needed.

• Must be a strong team player with excellent communication skills that will drive optimization of design control processes in collaboration with Quality, Regulatory & other key stakeholders' groups.

• Experience with cross functional project teamwork and collaboration with R&D, QA, RA, Marketing, Usability and Manufacturing team members.

• Strong team building and knowledge sharing skills to establish best practices, train and develop team members.

• Implement industry best practices and provide training, establish compliance metrics, and address or escalate issues for resolution.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor's degree and 7 years of relevant experience, or advanced degree and 5 years of relevant experience

Nice to Have:

• MBA preferred

• PMP Certification and/or certifications related to Quality

• Technical degree is a plus.

• Experience with Design Control documentation within medical device industry or Pharma industry.

• Experience conducting and organizing training, mentoring, and guidance for cross functional teams through design control and regulation requirements.

• Excellent written and verbal communication skills; ability to present information to cross functional audiences and management.

• Subject matter expert in all phases of product development lifecycle (design input/output and V&V).

• High degree of initiative and self-motivation.

• Prior work experience in a regulated industry (Medical Device Industry preferred)

• Sound experience and through knowledge of FDA 21/CFR Part 820 and ISO 13485

• Experience with Risk Management in medical devices is an advantage.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

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. Learn more about our benefits here (~~~) .

This position is eligible for a short-term incentive plan.? Learn more about Medtronic Incentive Plan (MIP) on page 6 here .

The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc. ??

tes of America)

Min Salary

155200

Max Salary

232800

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.