Sr. Regulatory Affairs Specialist

Cynosure, LLC.; Westford (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Cynosure, LLC. is seeking an experienced Regulatory Affairs professional to lead complex submissions and advise on labeling and regulatory filings worldwide. You will coordinate cross-functional teams to ensure compliance with FDA and international regulations.

The role requires 5–8 years in regulatory disciplines, strong communication, and demonstrated ability to manage multi-country submissions and changes. This on-site position offers growth within a leading medical aesthetics company.

Qualifications

• Bachelor’s degree required in engineering or a scientific field.
• 5–8 years relevant experience in Quality/Clinical/Regulatory disciplines.
• Experience with submitting 510(k)s is mandatory.

Responsibilities

• Completes submissions for complex regulatory markets with minimal supervision.
• Creates regulatory plans for cross-functional teams in design/development.
• Executes regulatory plans domestically and internationally.
• Provides regulatory guidance to product development teams.
• Maintains regulatory files and chronology; tracks document changes.

Skills

Regulatory submissions

FDA 510(k)

Regulatory compliance

Regulatory planning

Project management

Communication

Cross-functional teamwork

Documentation

Design controls

International regs

Problem solving

Education

Bachelor’s degree

Engineering or science field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Cynosure is well positioned competitively to lead and transform the medical aesthetics industry. We are guided by our belief that this is a purpose-driven business, which improves patient’s lives and improves practitioner’s livelihoods.

• We are passionate about driving a healthy and growing medical aesthetics industry with leading-edge marketing which inspires consumers to engage in medical aesthetics.
• We are the leader in science-based technology which elevates the standard of care for consumers.
• We are relentlessly focused on being the undisputed innovation leader, addressing the growing demand for consumer treatments across all demographics.
• We are committed to building and strengthening our unmatched global footprint, with direct employees on five continents and in 15 countries and growing, and distributor partners serving over 130 countries.
• We put our people first and believe personal development drives business development.
• We love our customers and strive give them the leading-edge technology, service, marketing support and clinical education to improve their patient’s outcomes and to improve their livelihoods.

At Cynosure, we look for people who make an impact and encourage everyone to lead, create, and add value. In turn, we invest in our team to grow people’s careers and build upon our high-performance and culture-oriented organization. We work together as one team, winning together.

As we grow our global team, there is no better time to join us. As a market leader in medical aesthetics, Cynosure has over 25 years developing, manufacturing, and marketing products for dermatologists, plastic surgeons, medical spas, and healthcare practitioners. With the aesthetic industry’s most comprehensive product portfolio, our offerings span several categories including skin revitalization, body contouring, hair removal, and women’s health.

Our mission is to set Cynosure customers up for success shaping future leaders of the aesthetics industry and helping everyone who uses our technologies discover their version of beautiful.

Learn more about us by following our LinkedIn and Instagram sites and please visit us at www.Cynosure.com.

Job Summary

Responsible for handling complex submissions with minimal supervision. Organizes regulatory information and tracks and controls submissions. Reviews and advises on labeling for compliance with regulatory filings. Reviews product changes for impact on regulatory filings worldwide. Research regulatory issues and provides guidance and advice to colleagues.

Essential Duties And Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• Completes submissions for countries that have complex requirements such as US FDA (510(k)s) Canada, China and/or EU with minimal supervision.
• Creates Regulatory plans for cross functional teams as input into design and development
• Executes Regulatory plans domestically and internationally
• Work interdepartmentally to satisfy international requirements during registration.
• Provide regulatory guidance to assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions.
• Timely compile materials for license renewals, updates and registrations.
• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
• Review labeling and labels for compliance with regulatory requirements.
• Review changes to existing products and SOPs to define the requirements for regulatory submissions.
• Provide regulatory reviews of customer complaints and define the regulatory reportability.
• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.
• Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes.
• Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management as required.
• Embody and live our company Values.

Qualifications

Education

Bachelor’s degree required

Specific Area of Study: Engineering or a scientific field

Experience

5 to 8 years relevant experience

Specific Related Experience: Within Quality / Clinical / Regulatory discipline.

Skills

• Excellent communication skills.
• Ability to manage multiple priorities.
• Requires creative, problem-solving ability and oral and written presentation skills.
• Team oriented, the ability to work in small team environment is essential; must also be a self-starter with the ability to work independently.
• Good planning and organization skills are vital.
• Strong critical thinking and problem-solving skills.
• Effective verbal and written communication skills are essential.
• Knowledge of US and international medical device regulatory requirements.
• Experience with submitting 510(k)s is mandatory.
• Experience with electromechanical and/or software devices is a plus.
• Strong understanding of design controls.
• International experience is required.
• Requires proficiency with standard software (Word, Excel, PowerPoint, etc.).
• The ability to meet deadlines and be detailed orientated is necessary.

Physical Demands

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

Cynosure is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran