Director Global Regulatory Affairs

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, Regulatory Affairs is a senior global leader responsible for defining and executing regulatory strategies that enable compliant, timely market access and lifecycle management of medical device products worldwide. This role emphasizes end-to-end regulatory problem solving, global alignment across regions/functions, and the implementation of AI and digital tools to modernize regulatory operations, improve efficiency, and enhance regulatory intelligence. They will partner closely with Quality, R&D, Engineering, Clinical, Manufacturing, Supply Chain, and Commercial teams to proactively manage regulatory risk, navigate evolving global frameworks, and support innovation across device portfolios.

Primary Responsibilities

Lead through Candela Values and reinforce a Quality Culture across the company.

• Develop and execute a Global RA Strategy including US, EU, UK, APAC, and emerging market regions based on market analysis and industry trends that consider both emerging customer needs/opportunities and emerging regulatory requirements.
• Own and resolve complex, cross-functional regulatory challenges by creating integrated, end-to-end solutions rather than isolated tactical fixes.
• Provide regulatory leadership across the full product lifecycle including concept development, design controls, clinical evaluation, submissions/renewals, post market surveillance, and for determination assessments on product change impact to inform bold RA strategies and decision-making on risk.
• Anticipate and mitigate regulatory risks related to health authority interactions, inspections, negotiations, design changes, manufacturing transfers, supplier changes, etc.
• Champion the adoption of AI-enabled tools and partner with relevant groups to design/employ automation, workflow optimization, and predictive analytics across regulatory processes.
• Drive continuous improvement using data-driven insights to reduce cycle times, improve submission quality, and enhance global regulatory consistency.
• Sets SMART goals, provides regular feedback on performance, and mentors others for career progression and success.
• Global accountability for establishment and maintenance of required Regulatory Compliance elements, QS certifications (i.e., MDR, MDSAP, etc.), and audit/inspection readiness.
• Establish/maintain a high-performance Regulatory Affairs team.
• Act as primary Candela 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 engineering, life sciences, or related discipline. Advanced degree strongly preferred.
• 10 years of regulatory affairs experience in the medical device industry including leadership of global regulatory strategies.
• Demonstrated experience/understanding of relevant global/regional medical device regulations and submissions with emphasis on MDSAP, UK, MDR, and APAC regions.
• Strong strategic and system-level thinking with a focus on end-to-end regulatory solutions.
• Deep working knowledge of global medical device regulations and standards.
• Demonstrated ability to leverage technology, automation, and AI to improve regulatory efficiency and effectiveness.
• Excellent leadership, communication, and stakeholder management skills across complex, matrixed, global organizations.
• Comfortable operating in ambiguous, highly regulated, and fast-paced environments.
• Enterprise mindset focused on scalable, sustainable regulatory solutions
• Digitally forward and innovative, with curiosity and openness to AI-enabled ways of working
• Balanced decision-maker, maintaining compliance while enabling speed and innovation.
• Collaborative leader who builds strong cross-functional and global partnership.
• Ability to communicate effectively both orally and in writing to cross-functional partners, senior leaders, 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.