Join a dynamic and innovative company at the forefront of the medical device industry. This business is dedicated to providing cutting-edge solutions that drive healthcare advancements and improve patient outcomes. With a strong commitment to quality, regulatory compliance, and product excellence, the company partners with global leaders to bring life-saving technologies to market. Offering a collaborative, fast-paced environment where your expertise can make a direct impact, and your career can grow alongside exciting industry developments. Be part of a team that is shaping the future of medical technology and advancing global health standards.
The Senior Regulatory Affairs Specialist is responsible for developing and executing regulatory strategies to support the timely registration, approval, and maintenance of company and client products. This role requires collaboration with cross-functional teams to ensure compliance with regulations and facilitate product commercialization.
Key Responsibilities:
* Lead the research and communication of regulatory pathways for new or modified products.
* Manage FDA submissions and Technical File development for medical devices, ensuring global compliance.
* Respond to requests from notified bodies, authorities, and distributors, preparing marketing approval documentation.
* Coordinate multiple projects, providing regular reports to management.
* Advise development teams (engineering, marketing, operations, quality) on regulatory requirements.
* Review proposed labeling and instructions for compliance with local and international regulations.
* Recommend changes to labeling, documentation, and reports to ensure regulatory compliance.
* Stay updated on regulatory changes and support continuous compliance review processes.
* Interact with regulatory agencies on specific matters.
* Support regulatory compliance activities, such as manufacturing site registration and GMP audits.
* Identify and implement best practices within the Regulatory Affairs Department.
* Communicate project status to senior management.
* Ensure alignment with global regulatory standards (FDA, EU MDR, ISO 14971) and support risk management file development.
* Collaborate with R&D, Quality, and Regulatory teams to mitigate biological risks and support product development.
Qualifications:
* Level 8 Honor’s Degree in Science or Engineering (bachelor's/master's) with 3-5 years of relevant experience in medical devices.
* Regulatory experience in Medical Devices, Pharmaceuticals, or similar regulated industries.
* Knowledge of ISO 10993, FDA requirements, EU MDR (Regulation (EU) 2017/745), and other international regulatory standards.
* Strong technical knowledge with critical thinking and decision-making skills.
* Ability to manage multiple projects and priorities, with excellent attention to detail.
* Problem-solving skills with the ability to identify and escalate issues.
* Excellent communication (verbal and written) and computer skills.
* Ability to provide guidance and training to others.
Seniority level
Mid-Senior level
Employment type
Full-time
Industries
Medical Equipment Manufacturing and Engineering Services
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