Regulatory Affairs Specialist - ET

Medtronic•Lafayette, CO

3d•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 Onsite 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 Reg ulatory Affairs Specialist ( RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as .  Primary responsibilities include : developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables . 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 have primary RA 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 developing and authoring regulatory submissions to 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/s cientific /t echnical area of focus with 2 + years of related experience , or a Masters degree with 0 years of experience.
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.

Nice To Haves

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
Some overnight travel

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 i nteract ions with regulatory authorities during the development and review process to ensure submission approval.
RA Representative on cross functional project teams to communicate regulatory r equirements , perform regulatory assessments and prepar e regulatory documentation according to a defined timeline.
Perform regulatory assessments on p roduct 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 a udit preparedness .
Other duties as assigned.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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)