NA Regulatory Specialist

Job Description

Job Description

Salary : $80,000 USD per year

COMPANY OVERVIEW

We believe in Excellence, Integrity, Agility, Rigor and Fearlessness. To consistently deliver on our promise of Better care. Better life, these five core values form the bedrock of our identity, culture and success. They give us a common purpose and we all collectively understand them, work towards them and live by them every day.

ROLE OVERVIEW

At 2San, we are at the forefront of innovation in the global healthcare industry, dedicated to improving lives with our principle of Better care. Better life. Our team in the US plays a pivotal role in this mission, focusing on the distribution and regulatory management of Class 2 and Class 3 Self-Test In Vitro Diagnostic devices (IVDs). As we continue to grow and disrupt the industry with our innovative products and solutions, we are looking for a Regulatory Specialist to join our dynamic team.

Key Attributes : HUNGRY, HUMBLE & SMART

KEY ACCOUNTABILITIES / RESPONSIBILITIES

• Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements.
• Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
• Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements.
• Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR).
• Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances.
• Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements.
• Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management.
• Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches.
• Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions.
• Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions.
• Engaging in regular communication with regulatory bodies, including the FDA, to facilitate product approvals, respond to queries, and maintain a positive working relationship.
• Coordinating with internal teams and external partners to ensure consistent and effective regulatory practices across all aspects of the business.
• Managing multiple projects and regulatory initiatives simultaneously, prioritizing tasks to meet deadlines without compromising quality or regulatory compliance.
• Keeping abreast of regulatory changes, trends, and best practices within the healthcare and IVD sector and disseminating relevant information to internal teams.
• Participating in continuous professional development activities to enhance regulatory expertise and staying informed of advancements in regulatory affairs and quality management.

KEY SKILLS & EXPERIENCE

TECHNICAL EXPERTISE

Essential :

Desirable :

Special Aptitudes :

Next Steps :

Your application will be reviewed by the hiring manager and if it is suitable for the position, we will reach out to arrange an initial interview.