General Summary

Candela is seeking a seasoned, passionate, and hands-on regulatory professional to join our global team as the Senior Manager of Regulatory Affairs responsible for APAC, LATAM, and MEA distributor markets, with a emphasis on Korea, China, and Japan.  This position will report to the Director of Regulatory Affairs.  Must possess proven leadership skills, enjoy working in a team environment, and offer exceptional strategic thinking skills.

Essential Job Functions

• Provide leadership and subject matter expertise regarding APAC, LATAM, and MEA regulatory affairs, with a specific emphasis on Korea, Japan, and China

• Create global regulatory strategies and timelines to align with business expectations and program management

• Familiarity with Quality System registrations, including Korean Good Manufacturing Practices (KGMP)

• Provide thought leadership and support to the Global Regulatory team (scoping of changes, advising on country-specific product and submission requirements)

• Oversee global regulatory interactions for product approvals

• Able to effectively interface, communicate, and negotiate with various global government authorities either directly or through subsidiaries or distributors

• Ability to manage stakeholders and work within a dynamic environment

• Provides expertise in translating global regulatory requirements into practical, workable plans

• Possess technical writing skills required to support regulatory submissions  

• Assess product changes for global regulatory impact

• Participate, mentor and coach team meetings related to regulatory pathway problem solving, effective team participation, and communication

• Manage and support RA associates responsible for APAC, LATAM, and MEA regulatory filings (4-5 team members)

• Provides training on regulatory issues and developments, as needed, to functions outside of RA (e.g., Clinical, Marketing, Engineering, Technical/Field Service, Quality)

   

Knowledge/Educational Requirements

• Fluency in spoken and written Korean

• Minimum of 7-years hands-on medical device regulatory affairs experience within APAC, LATAM, and MEA regulatory affairs, with a specific emphasis on Korea, Japan, and China

• Proven successful regulatory strategist from inception through approval process

• Direct experience with regulatory filings that require clinical data

• Strong leadership capabilities and communication skills

• Ability to solve problems and make sound regulatory decisions

• Excellent project management and task tracking skills 

• Proficient with MS Office applications

• Ability to travel up to 10% of time

• RAPS Certification (RAC) preferred

• Bachelor’s degree in life sciences or related field of study, master’s preferred

Essential Job Requirements (Required for Clinical and Regulatory Affairs Functions, remove section if not utilized)

• Fluency in Korea (written and spoken)

• Demonstrated success in the preparation, facilitation and completion of regulatory submissions within APAC, LATAM, and MEA regulatory affairs, with a specific emphasis on Korea, Japan, and China

• Develops regulatory submission strategies for APAC, LATAM, and MEA regulatory affairs, with a specific emphasis on Korea, Japan, and China including initial submissions, amendments, and routine renewals in support of business objectives

• Ensures that RA policies, procedures, and records are compliant with applicable regulations and standards

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.

Beware of fake job postings and offers. All official communications from Candela Medical will come from email addresses ending in @candelamedical.com. We will never ask for personal information such as Social Security numbers or bank details during the application process. If you receive a suspicious job offer or communication, please contact our recruitment team directly (hannah.elrick@candelamedical.com) to verify its authenticity.