We anticipate the application window for this opening will close on - 24 Jan 2025

 

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 Life

The Sr. Regulatory Specialist will provide both pre-market and post-market regulatory support for Neuromodulation and Pelvic Health.

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

• Provide regulatory support for both new and currently marketed products.  This includes developing regulatory strategies, reviewing submission deliverables, preparing submissions for regulatory agencies, reviewing changes to existing devices and recommending strategies for earliest possible approval for regulatory change submissions. 

• Leads or compiles all materials required in submissions, license renewal, and annual registrations. Supports internal audits and external inspections.

• Assists team members to support worldwide licenses and registrations as needed.

• Monitors and improves tracking/control systems.

• Keeps abreast of regulatory procedures, regulatory guidance, and regulations.

• May direct interaction with regulatory agencies on defined matters.

Required Knowledge and Experience: 

Must-Have: Minimum Requirements

• Requires a Baccalaureate degree

• Minimum of 4 years of regulatory affairs experience or advanced degree with a minimum of 2 years of experience.

Nice to Have:

• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and TUV), and working with cross-functional project teams.           

• In depth experience with FDA requirements, guidance documents, European Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards 

• Experience with Class III medical devices (PMA), including assessing and submitting changes

• Experience with Software as a Medical Device or cybersecurity regulations.

• Strong negotiation skills and written/oral communication skills

• Strong organizational skills and time management skills

• Ability to multitask, 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 

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.
 

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).