Medical Device Regulatory Affairs Specialist

We offer a competitive salary and benefits package, as well as a dynamic and collaborative work environment. If you are passionate about regulatory affairs and are looking for a challenging and rewarding opportunity, we encourage you to apply for this position.

Position: Medical Device Regulatory Affairs Specialist

Job Description: Our company is seeking a highly motivated and experienced Medical Device Regulatory Affairs Specialist to join our team. As a specialist in this field, you will play a crucial role in ensuring that our medical devices comply with all applicable regulations and standards. Your knowledge and expertise will be instrumental in obtaining and maintaining the necessary approvals and clearances for our products, allowing us to continue providing high-quality medical devices to patients and healthcare professionals.

Key Responsibilities:

• Develop and implement regulatory strategies for new medical devices, including product classification, risk assessment, and submission requirements.
• Prepare and submit regulatory submissions, such as 510(k)s, PMAs, and CE Mark applications, in compliance with FDA and international regulations.
• Serve as the primary point of contact for regulatory agencies, responding to inquiries and providing necessary documentation to support product approvals and clearances.
• Keep abreast of changes in regulations and standards related to medical devices, and communicate updates to internal stakeholders to ensure compliance.
• Collaborate with cross-functional teams, including R&D, Quality, and Marketing, to ensure regulatory requirements are considered throughout the product development process.
• Conduct regulatory reviews of product labeling, marketing materials, and promotional activities to ensure compliance with regulations and standards.
• Participate in regulatory audits and inspections, and assist in the development and implementation of corrective and preventive actions.
• Support post-market surveillance activities, including adverse event reporting and product complaints.

Qualifications:

• Bachelor's degree in a scientific or engineering field, with a strong understanding of medical device regulations and standards.
• Minimum of 3-5 years of experience in medical device regulatory affairs, preferably in a Class II or III device environment.
• In-depth knowledge of FDA regulations, ISO 13485, and other international regulations and standards.
• Experience with preparing and submitting regulatory submissions, and managing interactions with regulatory agencies.
• Strong attention to detail and ability to analyze complex information and data.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Ability to work independently and manage multiple projects simultaneously.
• Regulatory affairs certifications, such as RAC or CQA, are preferred.

Join our team and make a difference in the lives of patients worldwide.