Regulatory Affairs Specialist

Roles and Responsibilities :

Manages and coordinates international product registration submissions, oversees status of internal regional regulatory activities;

ensures compliance with relevant regulations and standards.

• Leads Regulatory on Global product registrations in a timely manner to meet the needs of the business for product growth and geographical expansion.
• Actively engages with cross-functional teams (as required) to plan for and provide regulatory guidance, services, and capabilities to support planned product launch and market expansion.
• Coordinates (pre) submissions and approval of all applications, ensuring they are accurate and appropriate to the requirements of the regions.
• Plans and tracks specified product registration and renewal activity, ensuring alignment with portfolio priorities throughout the registration and renewal processes;

manages expirations / renewals and planning for new applications.

Manages and oversees relationships and interactions with Health Authorities (HAs) to ensure the company's knowledge of requirements and expectations is current and robust;

shares this regulatory intelligence with colleagues to ensure the company is informed of opportunities and risks.

Participates in any relevant regulatory improvement projects.

Education and Experience :

• Bachelor's degree or higher in Life Sciences, Engineering, or related disciplines.
• Minimum of years plus experience in Regulatory Affairs.
• Experience working with Class I, II and III medical devices.
• Deep understanding of relevant laws, regulations, and guidelines governing the development, approval, and marketing of medical devices.
• Proven knowledge of regulatory requirements and experience preparing international documents, such as STEDs, Design Dossier, and Technical Files and new products registration for Non-EU, Canada, LATAM, APAC (Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA.
• Strong working knowledge of EU (MDD / MDR) medical device regulations and submissions.
• Experience and proven ability in preparing US regulatory submissions , IDE, (k), PMA, and technical documentation.
• Knowledge of Quality Systems requirements such as QSR, ISO , GxP.
• Strong leadership and project management skills and ability to manage complex projects and timelines within a team environment.
• Ability to identify compliance risks and escalate when necessary.
• Demonstrated ability to stay abreast of changing regulations and standards.
• Excellent computer aptitude and document formatting and publishing skills.
• Strong problem-solving skills and ability to deal with changing priorities.
Vor 30+ Tagen