Vice President, Regulatory Affairs

The Vice President, Global Regulatory Affairs is responsible for leading the development and execution of worldwide regulatory strategy and compliance initiatives. The RA leader is also responsible for maintaining all product registrations throughout the product lifecycle and working collaboratively with external partners and suppliers, while building and scaling a team in charge of driving change.

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.

Additionally, this role plays a key role in the company's overall continuous improvement program, defining the program's goals, developing systematic problem solving and management techniques, and facilitating team activities. The VP, Global Regulatory Affairs prepares the regulatory organization for the challenges that come with rapid global growth as we become a world market leader in high quality, leading edge, diabetes care products. Serves as Alternate Management Representative for the company as needed.

PRIMARY DUTIES & RESPONSIBILITIES:

• Provides regulatory leadership in the development of overarching US and international (OUS) regulatory strategy plan and execution details.
• Directs submission of information to regulatory bodies, including the FDA, EU, TGA and other regulatory authorities across the globe, including ensuring completeness, administrative and scientific accuracy; facilitating timely government approvals for marketing new and modified products; and managing global agency interactions.
• Provides definition and direction for digital health vertical and build complete regulatory strategy for all digital health products, collaborating with stakeholders to design new digital health processes.
• Provides leadership and support for regulatory intelligence function to gather relevant competitive insights through publicly available sources that can feed into business plans to increase the organizational knowledge of regulatory requirements and expectations globally.
• Builds and establishes operating mechanism for consistent understanding of regulatory requirements for pre-market and post-market accountabilities, building forums/channels to communicate progress and updates with cross functional teams on a regular basis.
• Builds meaningful regulatory affairs presence throughout the internal development process and with the company's executive leadership ensuring regulatory affairs guidance and influence is heeded early and consistently.
• Manages sustaining regulatory affairs activities and provide ongoing support for OUS tech file submissions and clinical trials.
• Works cross-functionally with the company's operations and quality functions to provide strategic and technical oversight for all regulatory compliance activities related to RFAI's, design and manufacturing issue impact assessments, FCA's, customer communications and agency interactions.
• Actively participates and provides guidance relative to managing regulatory inspections and audits and appropriately responding to any inquiries / observations.
• Identifies key regulatory issues and trends for senior management and proactively develop and deploy the necessary action plans.
• Contributes to the optimization and implementation of systems, processes, and procedures, including development of critical SOPs.
• Ensures succession planning at all levels and be the primary advocate for succession planning for regulatory affairs function with a focus on talent development, employee engagement and leading diversity, equity, and inclusion (DEI) activities.
• Oversees and guides a variety of personnel actions to include, but not limited to, hiring, performance appraisals, merit recommendations and promotions.
• Directs long and short-term planning for the department including headcount, budgeting, training, and systems requirements.

• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Other responsibilities as assigned.

BACKGROUND QUALIFICATIONS:

• 15 years of experience in Regulatory Affairs, preferably in the medical device industry.
• 10 years of experience at a Regulatory Affairs at management level.
• Global regulatory submission experience with Class I, II and III device environments.
• Knowledge of infusion pumps, preferred.
• Bachelor's degree (B.A/B.S.) in Health Sciences or Engineering or combination of equivalent education and applicable work experience.
• Master's Degree in a related engineering or Health Science discipline preferred.
• Previous experience working for a major global regulatory body as a lead reviewer and RAC Certification preferred.
• 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), CE Mark etc.) and preparing regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International).
• Proficient knowledge of US FDA, EMEA, Latin America and Asia PAC international guidelines.
• Demonstrated knowledge and understanding of FDA Good Manufacturing Practices "GMP", Quality System Regulations "QSR", ISO 9000 requirements, and in developing the systems and teams to operate effectively within these requirements.
• Familiarity with GLMP, Interoperability, SaMD, Cybersecurity, Medical Device Data Systems, Software Change paradigm, FDA's guidance on wireless technology.
• Proven leadership, team-building and mentoring skills, with a track record of building, leading, and working on teams, including ability to coach both peers and subordinates effectively.
• Excellent communication skills, ability to communicate effectively, both orally and in writing, to establish and maintain cooperative working relationships with persons inside and outside the business, including the ability to make effective and persuasive presentations both internally and externally.
• Professional presence, ability to represent the Company and the department internally and at business functions in a competent and professional manner.
• Comfortable operating in a high-growth environment and adaptable to evolving business priorities

• Proficient user of MS Office tools, including Word, Excel, PowerPoint, Access, Project Visio, etc.).
• Thorough knowledge of current medical device regulations and standards, such as ISO13485/IEC62304/ 14971/safety standards /FDA/ Security Standards/Data Privacy)
• Strong knowledge of lean manufacturing processes, computer and equipment qualification, validation, GMPs, ISO, and product/process validation.
• Adept at negotiating with notified bodies, vendors, and management and influencing senior level leaders regarding matters of significance to the organization.
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.