Job Description
Job DescriptionSalary: $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
- Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs.
- Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management.
- Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485.
- Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle.
- Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues.
- Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners.
- Proactive in identifying potential regulatory obstacles and developing effective solutions.
- Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously.
- Bachelors degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required; advanced degrees or certifications in regulatory affairs or quality assurance preferred.
- Commitment to continuous professional development in regulatory affairs and quality management.
- Staying informed about regulatory changes, trends, and best practices.
TECHNICAL EXPERTISE
Essential:
- A relevant bachelors degree in a scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering), or equivalent professional qualification.
- A minimum of 3 years of experience in regulatory affairs, candidates with experience with Self-Test IVDs preferred (but not essential).
- Experience with the FDA, Regulatory submissions, and compliance management within a fast-paced healthcare or related environment.
- Demonstrated ability to navigate complex regulatory frameworks and ensure compliance with US and international standards (e.g., ISO 13485).
- Proven track record of executing business improvement initiatives in the regulatory domain.
- Experience in troubleshooting regulatory problems and providing actionable recommendations.
- Ability to maintain confidentiality and exercise discretion in handling sensitive information.
- Excellent judgment and ability to adapt to changing regulatory landscapes.
- Capacity to manage and prioritize multiple projects and responsibilities simultaneously.
- Proficient in the use of the MS Office suite
- Experience within a fast-paced and high energy environment
Desirable:
- Advanced degree or professional certifications in regulatory affairs, quality assurance, or related fields.
- Experience in a global business environment, particularly with regulatory submissions in multiple jurisdictions.
- Familiarity with regulatory software or databases commonly used in the industry.
- Previous leadership or project management experience in a regulatory context.
Special Aptitudes:
- High-impact communication skills, capable of effectively liaising with regulatory bodies, internal teams, and external partners.
- Strong interpersonal skills to nurture collaborative relations across functions and with regulatory authorities.
- Relentless focus on achieving regulatory milestones and ensuring product compliance.
- Resilient under pressure, with a positive can do attitude towards challenges.
- Exceptional time management, analytical, decision-making, and problem-solving skills, essential for navigating the regulatory landscape.
- A proactive and agile work ethic, ready to respond to the dynamic needs of the regulatory environment.
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.