Regulatory Affairs Specialist at Medtronic

Ljubljana, Ljubljana, Slovenia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s or Master’s degree in Medicine, Pharmacy, Bioengineering, Chemistry or related field
Minimum of 2 years of relevant experience in regulatory affairs preferably in medical devices field
Fluent English (spoken and written)
Mandatory proficiency in Slovenian
Croatian knowledge an advantage
Highly motivated, strong customer focus
Good organizational skills
Good communication skills
Positive team spirit

Responsibilities

Collaborate with global / regional teams to build and maintain a submission plan for new launches, renewals and changes according to business strategy and establish mechanisms for tracking progress against set Key Performance Indicators (KPIs)
Collaborate with global teams and external partners (e.g. distributors) on sourcing & quality check of documents packages required for new registrations, renewals, changes and notifications submissions
Support regulatory requirements needed for importation and tender submissions
Manage Medical Device Directive (MDD) / Medical Device Regulation (MDR) Transition plan
Collaborate with global teams on post marketing vigilance activities execution including Field Safety Corrective Actions (FSCAs)
Keep abreast of regulatory procedures and changes
Interact with competent authorities and other external stakeholders
Maintain tracking / control systems
Oversee products regulatory activities for Albania, Bosnia & Herzegovina, Croatia, Kosovo and Slovenia to ensure complying with international and local regulations
Plan, execute, and coordinate with regulatory bodies, internal and external stakeholders for new products introduction and maintenance of existing ones

Skills

Key technologies and capabilities for this role

Regulatory AffairsMedical Device Directive (MDD)Medical Device Regulation (MDR)Regulatory SubmissionsPost Market SurveillanceField Safety Corrective Actions (FSCAs)Submission PlanningKPI TrackingStakeholder CoordinationImportation RequirementsTender Submissions

Questions & Answers

Common questions about this position

What compensation and benefits does Medtronic offer for this role?

Medtronic offers a competitive salary and flexible benefits package.

Is this Regulatory Affairs Specialist position remote or office-based?

This information is not specified in the job description.

What education and experience are required for the Regulatory Affairs Specialist role?

A Bachelor’s or Master’s degree in Medicine, Pharmacy, Bioengineering, Chemistry or related field is required, along with a minimum of 2 years of relevant experience in regulatory affairs, preferably in medical devices.

What is the company culture like at Medtronic?

Medtronic emphasizes purpose-driven innovation, leading with purpose to champion healthcare access and equity, while inspiring the extraordinary in a connected, compassionate world with a commitment to employees at the core of its values.

What skills make a strong candidate for this Regulatory Affairs Specialist position?

Strong candidates will have fluent English, mandatory proficiency in Slovenian, good organizational and communication skills, a highly motivated attitude with strong customer focus, and positive team spirit.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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