Regulatory Affairs Associate - Belgrade, Serbia

Job description

Regulatory Affairs Associate – Belgrade, Serbia

Fixed-term contract for 1 year

We are looking for a driven, detail and customer oriented Regulatory Affairs Associate, who will be responsible for ensuring that all regulatory requirements, necessary to obtain timely regulatory approval for any Medtronic distributed product (e.g. commercial medical devices and devices for clinical investigational use) within countries are met.

The Regulatory Affairs Associate will be also supporting Regulatory Affairs Specialist, the Marketing and Sales departments, distributors, and other stakeholders with providing the relevant information and documentation.

In return, we will provide the Regulatory Affairs Associate with excellent training, and the opportunity to work in a varied, challenging role with a large scope for demonstrating your independence, innovation and your talent.

Key Responsibilities

·  Obtain timely regulatory approvals to meet business objectives 
·  Support Regulatory Affairs Specialist with managing high volume of documents
·  Prepare and coordinate regulatory/registration submissions and ensure meet relevant external and internal requirements.
·  Ensure documentation, questions and answers from authorities and approvals are filed in the appropriate systems
·  Support in obtaining the necessary regulatory approvals when required by distributors
·  Coordinate the execution of Field Corrective Actions
·  Provide support for vigilance reporting to the regulatory authorities
·  Develop proficiency in any applicable regulatory requirement that apply to our products and ensure new or changed requirements are communicated within the organization

Skills & Qualifications

·  University degree in pharmacy, or medicine (dental medicine, veterinary, biology, chemistry sciences – optional)
·  Previous experience in a similar regulatory position in corporate environment, experience in medical devices industry is preferred
·  Fluency in English and Serbian languages
·  Strong skills in maintaining and administering high volume of documentation
·  Strong attention to detail and quality
·  General knowledge of “Good Documentation Practice”
·  Excellent Computer skills (MS Office)

Other requirements

·  Experience in working with Government officials
·  Experience I working with complex databases
·  Strong Customer focus mindset, adaptability

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.  Help us shape the future.