Associate Regulatory Affairs Specialist

Medtronic • Lafayette, CO

4d • Onsite

About The Position

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 As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. Our Cranial & Spinal Technologies (CST) operating unit advances surgical care for spine and cranial conditions through an integrated ecosystem of implants, navigation, robotics, imaging, and planning tools. Platforms like AiBLE enhance precision, efficiency, and outcomes for complex procedures worldwide. Check us out on LinkedIn: Medtronic CST At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. The Regulatory Affairs Associate supports regulatory strategy and submissions to ensure medical devices comply with applicable global regulatory requirements. The role assists in preparing documentation, maintaining regulatory files, and coordinating with cross functional teams to obtain and maintain product approvals. Additionally, supports regulatory activities to maintain internal data integrity for products already in the marketplace. This role primarily focuses on regulatory support for the US and EU markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will collaborate with RAS and Sr. RAS on responsibility for multiple Class II and/or Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence. From supporting internal systems, supporting regulatory submissions and providing critical input on cross-functional development project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company.

Requirements

• Bachelor’s Degree in Engineering, Life Sciences, or related medical/scientific/technical area of focus
• Understanding of engineering concepts and scientific terminology
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationale
• Experience reviewing technical and design specifications
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Superior interpersonal skills
• Excellent analytical thinking skills
• Ability to effectively manage multiple projects and priorities
• Proven ability to work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Strong organization and time management skills
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• 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.
• Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Responsibilities

• Supports coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies.
• Able to write regulatory justifications to support submission filing decisions.
• Supports compiling and producing materials required in submissions, license renewal and annual registrations.
• Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
• Supports interactions with regulatory authorities during the development and review process to ensure submission approval.
• RA Representative on cross functional project teams to communicate regulatory requirements, perform regulatory assessments and prepare regulatory documentation according to a defined timeline.
• Perform regulatory assessments on product changes that may be initiated internally or externally.
• Recommend changes for labeling, manufacturing, marketing, and clinical documentation for regulatory compliance.
• Review and approve engineering change orders per company procedures, to assure compliance with regulatory requirements.
• Work with global regions to solve internal regulatory blocks within the supply chain.
• Creation and/or maintenance of Technical Document, GSPRs, Declaration of Conformity, Risk Classification Assessments.
• Review and assess impact of NCMRs in a timely manner to support manufacturing goals.
• 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 with the company.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle maintenance and develop solutions with other members of regulatory and related teams.
• Participation in internal and external audit preparedness.
• Maintain regulatory databases and document management systems.
• Other duties as assigned.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level