Regulatory Specialist Jobs

2San

Location:
United States, Norwood

Category:
Health and Beauty

Contract Type:
Employment contract

Salary:

80000.00 USD / Year

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Job Description:

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.

Job Responsibility:

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.

Requirements:

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
Bachelor’s 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.

Nice to have:

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.

Additional Information:

Job Posted:
December 01, 2025

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Regulatory Specialist