Sr. Regulatory Affairs Specialist II

Tandem Diabetes Care•California - High Bluff, CA

2d•Hybrid

About The Position

The Sr. Regulatory Affairs Specialist is responsible for developing strategies for worldwide regulatory approval to introduce new products to market, maintaining existing products, providing advice on regulatory requirements, preparing worldwide submissions, and negotiating their approval with the agencies. As a subject matter expert, this role drives continuous improvement of key business and regulatory processes to ensure compliance with regulations set forth by the USFDA, International Regulatory Agencies, and in conformance with Good Manufacturing Practices, 21CFR Part 820, 21CFR Part 803, 21CFR Part 806, European MDD, MDR and ISO 13485. The ideal candidate for this role will have prior experience supporting class III devices per Regulation (EU) 2017/745 requirements. Sr RASs at Tandem are also responsible for serving as the regulatory lead on sustaining engineering project teams, providing regulatory assessment of the impact of design and manufacturing changes on medical devices in markets such as the EU, UK, Australia, Israel, and Saudi Arabia. They also review medical device promotional materials for compliance to US and international regulations, serve as a lead on product design/development project teams, and review and complete US and OUS submissions as directed, liaising with health authorities as needed. This role acts as a Tandem representative in regulatory inspections as needed and provides regulatory strategy, guidance on risk assessment, and required corrective action to meet requirements from product ideation to premarket submissions/registrations, product launch, and post-market compliance, working closely with healthcare regulatory bodies globally. Additionally, the role interprets Medical Device regulations, with a particular emphasis on Digital Health and Software as a Medical Device (SaMD), and provides direction to product teams in understanding the impact of such regulations on existing and new Digital Health products and solutions. The specialist identifies gaps in product development plans that may pose regulatory issues and develops novel development strategies. They also review and analyze project and customer requirements and assist project teams in tailoring and using regulatory procedures, methods, templates, and tools, ensuring compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

Requirements

Bachelor's degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience.
7+ years of related experience in regulatory function in medical device or health IT industry.
Demonstrated experience in leading, designing, writing, and submission of regulatory filings and correspondence and/or approvals, including experience authoring a range of global regulatory submissions, (e.g., 510(k), De Novo, CE Mark etc.) and preparing regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International).
Proficient knowledge of quality standards: ISO 13485, 21CFR Part 820 and other appropriate industry standards.
Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
Significant experience with products containing software, including knowledge of the software life cycle.
Working knowledge of IEC 60601-series standards, specifically IEC 62304.
Prior experience with medical device software (MDSW) and active medical devices.
Ability to translate and simplify technical content or regulations and communicate to stakeholders.
Strong understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies globally for diagnostic/digital health tool development and approval, with particular focus on EU/UK.
Demonstrated experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies.
Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the product development and commercialization process.
Ability to recognize non-conformances from accepted and documented practices.
Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
Skilled at creating a cooperative team environment.
Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.
A positive approach to people and problem solutions along with a strong sense of discretion and the ability to maintain confidentiality.

Nice To Haves

Regulatory Affairs Certificate, preferred.
Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
Prior experience supporting class III devices per Regulation (EU) 2017/745 requirements.

Responsibilities

Serves as regulatory lead on sustaining engineering project teams providing the regulatory assessment of impact of design and manufacturing changes on medical devices in markets such as the EU, UK, Australia, Israel, Saudi
Reviews medical device promotional materials for compliance to US and international regulations.
Serves as a lead on product design/development project teams.
Reviews and completes US and OUS submissions as directed; liaising with the health authorities as needed.
Acts as Tandem representative in regulatory inspections as needed.
Provides regulatory strategy, guidance on risk assessment and required corrective action to meet requirements from product ideation to premarket submissions/registrations, product launch and post market compliance, working closely with healthcare regulatory bodies globally.
Interprets Medical Device regulations, with a particular emphasis on Digital Health, Software as a medical device (SaMD), and provides direction to product teams in understanding the impact of such regulations on existing and new Digital Health products and solutions.
Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies.
Reviews and analyzes project and customer requirements and assist project teams in tailoring and using regulatory procedures, methods, templates and tools.
Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.