Regulatory Affairs Specialist

at  Medtronic

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.

REQUIRED KNOWLEDGE AND EXPERIENCE:

• Bachelor’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 both spoken and written.
• Highly motivated, strong customer focus.
• Good organizational skills.
• Good communication skills.
• Positive team spirit.

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.

• Co-ordination and preparation of documents packages required for notifications submission and licenses maintenance.
• Supporting regulatory requirements needed for importation and tender submissions.
• Managing Medical Device Directive (MDD) / Medical Device Regulation (MDR) transition plan.
• Overseeing the execution of post marketing vigilance activities including Field Safety Corrective Actions.
• Keeping abreast of regulatory procedures and changes.
• Interaction with competent authorities and other external stakeholders.