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Director, Global Regulatory Affairs

Requisition Number **2872**

Location **US - Marlborough, MA**

State/Territory **Massachusetts**

Company Overview:

Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. We are the market leader in the development, and distribution of medical and aesthetic laser and light-based technologies. The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic application including hair removal, wrinkle reduction, tattoo removal, improving the skin’s appearance through the treatment of benign vascular and pigmented lesions, and the treatment of acne, leg veins and other common indications.

The Company is headquartered in Marlborough, Massachusetts, USA, with an additional R&D facility in Yokneam, Israel and commercial locations across Asia Pacific, and Europe. Products are sold directly in 18 countries worldwide and are supported by capital sales, field service, clinical education, technical support and marketing development organizations. Candela maintains contracted distributors in over 60 other countries.

General Summary

The Director, Global RA will be fully accountable for Candela’s RA functions worldwide and for driving transformational improvement to create Regulatory operational excellence, simple/robust processes, and an environment of disciplined execution. The successful candidate will have the relevant expertise, experience, and motivation to drive meaningful process/product improvements. They will exemplify high technical skills, global leadership, team development acumen, collaboration, change management skills, the ability to mentor junior employees, and to effectively communicate with senior management.

Essential Job Functions

+ Leads through Candela Values, holds others accountable for embodying Candela Values, and reinforces a Quality Candela Culture across the company.

+ Develops and executes the Global RA Strategy based on market analysis and industry trends that consider both emerging customer needs/opportunities and emerging regulatory requirements.

+ Provide global leadership and subject matter expertise on all RA topics required for both tactical and strategic initiatives.

+ Possess and exercise regulatory and medical device industry relationships to inform bold RA strategies and decision-making on risk.

+ Effectively establishes and communicates a “done right the first time” vision and aligns others around the required strategy, objectives, and plans.

+ Encourages/demonstrates responsible risk taking to achieve results.

+ Builds (establishes) a culture of action and accountability for on-time deliverables.

+ Sets SMART goals, provides regular feedback on performance, and mentors others for career progression and success.

+ Anticipates obstacles and creates risk based contingency plans to achieve AOP/LT strategy in a changing environment.

+ Shows active and visible commitment to efficiency programs and continuous improvement initiatives including using data, trend analysis and other methods to streamline RA and related processes.

+ Identifies and incorporates external and internal best practices into business processes to add new capabilities and drive efficiencies.

+ Collaborates across functions to drive end to end solutions within and across competing priorities to build internal support, create synergies, and achieve operating goals.

+ Global accountability for establishment and maintenance of required Regulatory Compliance elements, QS certifications (i.e., MDR, MDSAP, etc.), and audit/inspection readiness.

+ Global accountability to establish/maintain a high-performance Regulatory Affairs team.

+ Actively support New Product Introduction (NPI) and Sustaining Engineering processes/assignments.

+ Establish and maintain processes to meet/exceed all regulatory submission/approval dates.

+ Developing and maintaining partnerships with global regulatory agencies and act as Candela’s primary contact for Authorized Representatives and all direct regulatory agency interactions.

+ Lead / facilitate effective management of problem resolution processes including corrective and preventative action (CAPA) management, NC management, and any other activity to resolve/improve a Candela business process.

+ Support the successful integration of acquisitions into the global QMS and Regulatory scheme.

+ Collaborate on the review of Marketing/labeling content to deliver the RA risk perspective.

Knowledge/Educational Requirements

+ Bachelor’s Degree in an area of life sciences/engineering/related field, plus 12 years of experience in the medical device industry with at least 10 years in a management/leadership role.

+ Assessing the external environment to drive inputs to a global PLM plan to accelerate future regulatory approvals, while staying current with global standards such as MDSAP/MDR/and other global regions.

+ Development and leading successful execution of 5-year plans, to accelerate growth in key global markets. project plans, status meetings, reporting, and closure.

+ Experience in the development, tracking on regulatory KPI’s, Dashboards, and Risk/Mitigations

+ Ability to develop and lead teams in a dynamic and changing Environment.

+ Ability to partner, develop and maintain collaborative relationships with global regulatory bodies.

+ Accustomed to a high-performance environment demands a self-motivating leadership/management style.

+ Demonstrated analysis of data and trends to accelerate performance and drive efficiencies.

+ Ability to analyze information and come to conclusions based on available data.

+ Ability to communicate effectively both orally and in writing including to cross-functional partners, senior management, customers, and regulators.

+ Strong leadership capabilities with a track record of recruiting and developing talent.

+ Demonstrated competency in computer skills: MS office applications, query tools, enterprise database systems, ServiceMax, and Oracle is desired.

_This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management._