Medtronic Jobs

Careers that Change Lives

The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and EU submissions and maintaining approval for products. Additionally, the Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

A Day in the Life

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

• Leads or compiles all materials required in submissions, license renewal and annual registrations.

• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

• Monitors and improves tracking / control systems.

• Keeps abreast of regulatory procedures and changes.

• May direct interaction with regulatory agencies on defined matters.

• Recommends strategies for earliest possible approvals of clinical trials applications.

• Responsible for reporting complaints and Adverse Drug Reactions (ADR)

• Define the regulatory strategy and manage regulatory submission activities for product maintenance for existing approved products.

• Team with operating unit Regulatory Affairs Specialists (RAS) and international

regulatory team to provide regulatory support changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

• Prepare regulatory (e.g., FDA/Notified Body) submissions for product changes, as required, to ensure timely approvals for market release.

• Review significant product submissions with manager and negotiate submission issues with agency personnel.

• Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.

• Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.

• Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.

• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

• Provide business and product information to international regulatory team to enable development of strategies and requirements and communicate that information to business teams.

• Ensure personal understanding of all quality policy/system items that are personally applicable.

• Follow all work/quality procedures to ensure quality system compliance and high quality work.

Must Have: Minimum Requirements

KNOWLEDGE/EDUCATION

• Bachelor’s degree, or;

• Advanced degree.

• Knowledge of products and therapies.

JOB EXPERIENCE

• Minimum of 4 years of relevant experience, with a bachelor’s degree, or

• Minimum of 2 years relevant experience, with an advanced degree.

• Experience in Regulatory Affairs or related field

• Proven experience with drug or device regulatory/submission process.

• Regulatory Agency experience.

• Business Development.

SKILLS/COMPETENCIES

• Demonstrated leadership competencies.

• Effective at influencing and building strong working relationships across all levels.

• Negotiation Skills.

• Technology Expertise.

• Business Acumen.

• Demonstrated organizational abilities.

• Good Communication skills.

• Excellent Computer Skills.

• Medtronic Competencies.

• Strong interpersonal and communication skills at all levels of the organization.

• Proven track record of good judgment.

• Demonstrated integrity and respect for all.

• Attention to detail.

• Strong problem solving and results driver.

• Ability to manage multiple priorities in a fast-paced environment.

Nice to Have

KNOWLEDGE/EDUCATION

• RAC certification

Salary Range: 86K - 129K

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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.