Strategy and Planning Regulatory Affairs Specialist

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 Life

We 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.

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

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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).