Medical Devices Regulatory Affairs Specialist

MedTech Innovations offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive workplace and welcome applications from all qualified candidates. If you are a motivated and detail-oriented individual with a passion for regulatory compliance in the medical device industry, we encourage you to apply for this exciting opportunity.

Position: Medical Devices Regulatory Affairs Specialist

Location: Kecskemét, Hungary

MedTech Innovations is seeking a highly skilled and experienced Medical Devices Regulatory Affairs Specialist to join our dynamic team. As a leader in the healthcare industry, we are dedicated to providing innovative medical devices that improve the lives of patients around the world. This is an exciting opportunity for an individual who is passionate about regulatory compliance and has a strong understanding of medical device regulations.

Key Responsibilities:

• Develop and implement regulatory strategies for the approval of medical devices in various global markets.
• Ensure compliance with all applicable regulatory requirements and standards, including FDA regulations, EU Medical Device Regulation (MDR), and other international regulations.
• Maintain and update regulatory submissions, including 510(k) applications, technical files, and design dossiers.
• Review and approve promotional and labeling materials to ensure compliance with regulatory requirements.
• Provide guidance and support to cross-functional teams during product development and post-market activities.
• Conduct regulatory research and analysis to stay current with changes in regulations and standards.
• Collaborate with international regulatory authorities and notified bodies to obtain approvals and clearances for medical devices.
• Participate in audits and inspections by regulatory authorities.
• Train and educate internal teams on regulatory requirements and updates.

Qualifications:

• Bachelor's degree in a scientific or technical field.
• Minimum of 3-5 years of experience in medical device regulatory affairs.
• Thorough understanding of FDA regulations, EU MDR, and other international regulations.
• Strong knowledge of medical device regulations and standards, including but not limited to ISO 13485, ISO 14971, and IEC 60601.
• Experience with regulatory submissions, including 510(k) applications, technical files, and design dossiers.
• Excellent communication and interpersonal skills.
• Strong attention to detail and ability to work in a fast-paced, deadline-driven environment.
• Ability to work independently and in a team setting.
• Proficient in Microsoft Office and other relevant software.

Join us in our mission to improve the lives of patients and make a difference in the healthcare industry.