Associate Regulatory Affairs Specialist - Onsite

Medtronic•Fort Worth, TX

14h•Onsite

About The Position

Medtronic is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life. The Neuroscience portfolio, specifically the Cranial & Spinal Technologies (CST) operating unit, focuses on advancing surgical care for spine and cranial conditions. This role is part of a team that works a minimum of 4 days a week onsite to foster professional growth and collaboration. The Associate Regulatory Affairs Specialist will support regulatory activities throughout the medical device Total Product Lifecycle (TPLC), including product maintenance and global submissions. This involves supporting changes to labeling, manufacturing, marketing, and clinical documentation to ensure regulatory compliance, compiling submission materials, and preparing document packages for regulatory submissions, audits, and inspections. The role also involves staying updated on regulatory procedures and changes, and potentially interacting with regulatory agencies.

Requirements

Requires a Baccalaureate degree
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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.
Candidates below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

Open to feedback and continuous improvement
Experience /knowledge of MS Office Suite
Strong critical thinking and cross-functional collaboration skills
Ability to synthesize regulatory information for clear stakeholder communication
Self-starter with strong accountability and independent work style
Strong organizational skills with the ability to manage shifting priorities while maintaining quality and accuracy

Responsibilities

Supports cross-functional teams with changes as part of the Total Product Lifecycle (TPLC) with support from more senior team members
Supports changes to labeling, manufacturing, marketing, and clinical documentation to ensure regulatory compliance.
Compiles materials required for submissions, license renewals, and annual registrations.
Supports the preparation of document packages for regulatory submissions, internal audits, and inspections across all areas of the company.
Keeps abreast of regulatory procedures and changes.
May participate in interactions with regulatory agencies on defined matters.
Monitors and improves tracking/control systems.

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)