Strategy and Planning Regulatory Affairs Specialist

Posted 5 Days Ago
Be an Early Applicant
9 Locations
In-Office or Remote
28K-1M Annually
Junior
Healthtech
The Role
Develops and maintains regional regulatory submission plans for medical device launches, renewals, and updates across ACEE and TURMECA markets. Coordinates with regional, global, and center-led regulatory teams on prioritization, documentation, harmonization, and process improvement. Tracks milestones, identifies risks, reports progress, and maintains country-specific regulatory guidance on requirements, timelines, and fees. Requires medical device regulatory affairs experience, EU MDR or global regulatory knowledge, project management, analytical, communication, and collaboration skills.
Summary Generated by Built In

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the LifeWe believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. This role serves as a key driver for developing strategies to introduce new products and therapies and maintain existing products in the Africa & Central Eastern Europe (ACEE), Turkey, Middle East, Central Asia and Russia (TURMECA) markets. The individual in Strategy and Planning Regulatory Affairs (S&P RA) Team partners closely with regional and cross functional experts to facilitate streamlined approach for pre-market submissions (registration and notification) planning and execution.
There is no fixed reporting location for this hybrid working model, but the role might require coordination across time zones and fluent business English. Limited/occasional travel may be required depending on project needs and stakeholder engagement.

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

  • Drive collaboration and engagement with ACEE & TURMECA QRA sub-regional teams and Strategic Market Enterprise to build and maintain a regional submission plan for new launches and renewals/updates according to regional business strategy for the assigned product groups. 
  • Liaising with Global Operating Units (OU) RA teams to manage submission prioritization and address documentary challenges for local ACEE & TURMECA submissions and notifications. 
  • Work closely with the Center-Led (CL) RA Submissions team to represent ACEE & TURMECA sub-regions in pre-market submission harmonization, standardization, and process improvement projects.
  • Collaborate with CL RA Submissions team to identify opportunities and solutions for document sharing collaborations across regions and facilitate essential submission deliverables to in-country RA teams within ACEE & TURMECA to improve approval timeliness in those regions.
  • Track submission milestones and progress, identify risks early, and report regularly.
  • Keeping abreast of new and changing regulatory requirements impacting submission/notification plans and maintaining guidance documents on ACEE & TURMECA in-country submission requirements, timelines, fees, as a reference for relevant stakeholders.


Required Knowledge and Experience:

  • Bachelor’s Degree in scientific/ engineering discipline or relevant fields
  • Minimum 2-3 years of experience in regulatory affairs for Medical Devices
  • Proven expertise in regulatory affairs, (nice to have in strategy planning and submission preparation)
  • Knowledge about EU MDR regulations, or global regulatory requirements
  • Highly motivated and results-oriented individual
  • Demonstrated interpersonal skills
  • Ability to flex and adapt to changing priorities
  • Ability to handle advanced concepts and undefined paths
  • Effective project management skills and experience
  • Basic knowledge of AI automation is nice to have (e.g., using AI features within Copilot)
  • Critical thinking and data analysis skills to evaluate submission data and identify potential risks
  • Effective oral and written communication skills in English
  • Ability to travel approximately 10%

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. 

Recruitment Fraud Alert 

We are aware of phishing scams targeting job seekers. Please keep the following in mind: 


Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 


Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 


If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 


If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]



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.
 


Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik:  Croatia: 36,000.00 EUR - 54,000.00 EUR | Czechia: 732,000.00 CZK - 1,098,000.00 CZK | Poland: 125,600.00 PLN - 188,400.00 PLN | Slovakia: 27,840.00 EUR - 41,760.00 EUR | 
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Skills Required

  • Bachelor's degree in a scientific, engineering, or relevant discipline
  • 2–3 years of medical device regulatory affairs experience
  • Expertise in regulatory affairs
  • Knowledge of EU MDR regulations or global regulatory requirements
  • Interpersonal and collaboration skills
  • Ability to adapt to changing priorities
  • Ability to handle advanced concepts and undefined paths
  • Project management skills and experience
  • Critical thinking and data analysis skills
  • Effective oral and written communication skills in English
  • Ability to travel approximately 10%
  • Experience in strategy planning and submission preparation
  • Basic knowledge of AI automation, such as Copilot features

Medtronic Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.

  • Healthcare Strength Health coverage is considered comprehensive, with high-quality medical, dental, and vision options through major providers and added mental-health resources. These programs are frequently highlighted as a core strength of the package.
  • Parental & Family Support Parental and family benefits stand out, including up to 24 weeks paid leave for U.S. birthing parents, 12 weeks for other parents, and a global Family Care Leave at 100% pay. Family-building support (fertility, adoption/surrogacy reimbursements) and backup care further reinforce this strength.
  • Retirement Support A 401(k) with company match is described as competitive and reliable for long-term savings. Additional financial programs, such as tuition assistance and charitable-gift matching, complement retirement planning.

Medtronic Insights

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The Company
HQ: Dublin
80,303 Employees
Year Founded: 1949

What We Do

Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.

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