Would you like to work for a rapidly growing international healthcare company?
Join Medtronic, where we appreciate your talent, experience and passion for your work. You can count on professional and personal development, exciting challenges and a dynamic environment.
For this Sr. Regulatory Affairs Specialist role, you would be expected to be located in İstanbul or willing to relocate.
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.
- University degree in Engineering or related fields
- Minimum 4 years of experience in Regulatory Affairs departments
- Preferred to have experienced in medical device or pharma industry
- Excellent communication skill both in English and in Turkish
- Good level of MS Office Applications
- Strong planning, follow up, reporting and analytical skills to achieve accurate and timelyresults
- Work precisely according to procedures, rules and regulations
- Recognize recurring issues and analyse their causes in order to reach a solution
- Strong command of communication and presentation skills
- No military obligation for male candidates
JOB DESCRIPTION MAIN PURPOSE OF JOB :
Prepare applications for the permits, licenses, certificates, authorizations, and other approvals that the organization needs to conduct its business activities; and produce, sell, and distribute its goods and services. These may include product licenses, manufacturing, import and export permits. Prepare and coordinate registration and development of trademarks for the organization’s range of products.
Well developed, advanced knowledge and skills for assisting with the registration process in ensuring approvals of new products, manufacturing permits, import permits and amendments to products. Provide advice to marketing, research, finance and other related departments on outlining registration component needs and timing. Maintain currency on regulatory conditions.
- Manage and facilitate all registration related activities
- Document and maintain the product dossiers, certification applications and filings required to operate.
- Communicate regularly with local authorities and ensure company policies strictly adhere to statutory requirements.
- Establish and maintain positive relationships with government agencies and other regulatory authorities.
- Assist the area in relation to processes of product qualification and certification with government regulatory agencies.
- Prepare materials for legal counsel or external consultants.
- Assist Regulatory Affairs Manager in all processes to ensure the organization’s regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
- Implement QA systems and generate SOPs
- Deal with quality related questions and complaints