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.
ROLE PURPOSE
The International Regulatory Director will be anticipating and shaping the environment across International, enabling Cynosure International to lead through innovation.
Role is responsible to lead and/or participate in cross functional and cross company interdisciplinary teams responsible for defining and implementing regulatory strategy in Europe, Middle East, Asia and Latin America. Manage regulatory interactions with distributors, consultants or partners to achieve regulatory objectives in line with individual development and corporate goals. Will be the PRRC for Cynosure's Authorized Representative and Importer facility. Primary contact with regulatory authorities in Europe.
Strategic Role Responsibilities

• Establish Cynosure as a shaping influence in the regulatory environment across key markets
• Create International RA strategy and ensure it dove-tails and complements the Global Strategy
• Shorten lag times between innovation and ability to implement in global key markets

1. Deep dive into key Asian markets and establish root cause issues for lag times
2. White paper of fast changing regulatory environment

• Scan changing ongoing regulatory environment and proactively incorporate changes into strategy as well ensure business readiness
• Within the approved strategy set clear priorities and achieve alignment with key stakeholders

Operational Role Responsibilities

• Manage and resolve the tension between global excellence and new innovation with local execution challenges
• Drive Efficiency

1. Ensure EU in country notifications are completed on time.
2. Improve internal systems/processes to ensure ability to be proactive in approach (eg planning)

• Drive Effectiveness

3. Support post-market surveillance efforts monitoring the performance of Cynosure devices.
4. Ensure competent execution of agreed priorities through working with all relevant stakeholders and guard against distraction/ competing enterprise asks
5. Ensure all International marketing material is in line with local regulatory requirements

• Leverage regular Influencing Conversations to build Cynosure's shaping influence

6. Maintain communication with Competent Authorities and Notified Body as necessary.
7. Support the conversion from the EU Medical Device Directive to the Medical Device Regulation
8. Oversee the creation and maintenance of agreements between the EU importer and the EU distributors who will be placing the devices on the market.
9. Manage regulatory interactions with distributors, consultants or partners
People & Leadership Responsibilities

• Lead/participate in cross functional and cross company interdisciplinary teams establishing international regulatory strategy for commercial products.
• Play a thought and people leadership role within the Global RA community
• Build strong teams with peers and local market experts based on functional expertise and mature leadership personality
• Represent RA in the International Leadership Team, creating transparency through proactive collaboration within the matrix

FUNCTIONAL EXPERTISE

• Submission of Technical File and/or Design Dossiers to Notified Body in EU.
• Experience in supporting international registrations
• Excellent knowledge of MDD and MDR, and ISO13485.
• Strong understanding of marketing and promotional requirements in Europe and Asia.
• Strong working knowledge of FDA regulations, including knowledge of medical device development process and related FDA regulations across full product life cycle
• Experience with ISO 14155 and other clinical regulatory requirements is a plus
• Strong project organization and time management skills, including the ability to prioritize multiple challenging project timelines while ensuring all deadlines are met

SOFT SKILLS

• Strong attention to detail and well-developed analytical thinking skills
• Ability to take initiative and work autonomously without significant direction, implementing judgment to resolve objective
• High level of spoken and written English
• Strong influencing and negotiating skills with very senior internal and external stakeholders
• Excellent communication skills; written and verbal
• Learning Agility, with emphasis on Mental agility and Change agility
• Strong conceptual thinking
• Strong problem-solving skills
• Passion for results
• Strong matrix influencing skills
• Building organizational talent
• Proven ability to balance autonomy and collaboration
• Is resilient
• High level of integrity
• Accurate self-insight
• High learning orientation
• Calm under pressure

Qualifications (Select the minimum qualifications required for this position to successfully achieve business requirements)
Education

• Associate's degree required
• Bachelor's degree required
• Master's degree required
• PhD required
• Education and experience combination:
• Associate's degree is equivalent to 18 months of experience
• Bachelor's degree is equivalent to three (3) years of experience
• Master's degree is equivalent to four (4) years of experience

Specific Area of Study:
Experience

• 0 to 2 years relevant experience
• 2 to 5 years relevant experience
• 5 to 8 years relevant experience
• 8+ years relevant experience

Specific Related Experience:

• 15+ years' experience in a medically regulated and technical environment with at least 5+ years in a medical device company.
• Min5 years of people leadership in a matrixed and geographically environment

Skills
Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• 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.
• Lifting/pushing/pulling and carrying products weighing up to 45 pounds
• Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Potential Exposure to hazardous chemicals or other materials.
• Safety Shoes compliant with site specific policies/procedures must be worn in designated areas
• Potential Exposure to blood.
• Other (please specify)

Cynosure is an equal opportunity employer aiming for inclusion and diversity in every recruitment process.