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    Senior Manager, Regulatory Affairs - Westford, United States - Cynosure

    Cynosure
    Cynosure Westford, United States

    6 days ago

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    Description
    Posted Saturday, April 6, 2024 at 4:00 AM
    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.

    Responsible with collaboration, design and implementation of the worldwide regulatory strategy for all products.
    Essential Duties and Responsibilities
    Responsible for the oversight of Regulatory Affairs as directed.
    Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary.

    Manages the collection and coordination of information to prepare regulatory documentation packages for review and submission to regulatory agencies, subsidiaries or to commercial partners.

    Plans, prepares, and manages timelines for assigned regulatory tasks including, but not limited to initial submissions, meeting requests, protocol assistance, etc., ensuring that timings are supportive of the corporate goals.

    Leads the effort to support new product development and provide submission requirements for gaining market approval in the US and worldwide as part of the design controls process.

    Supports the development and assessment of regulatory requirements for clinical and preclinical programs to assure all development activities are in compliance with applicable regulations and guidelines.

    Reviews document and product changes for regulatory submission impact and carries out necessary change notification submission requirements as required.
    Reviews labeling, promotional materials and training materials for regulatory compliance.
    Maintains State Licenses, Registrations and other certifications as required to maintain regulatory and product approval compliance. Manages the compilation materials for license renewals, updates and registrations.
    Understands and communicates US and OUS regulation requirements. Actively reviews new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicates information to management.
    Complete activities as Person Responsible for Regulatory Compliance (PRRC) for Cynosure.
    Provides regulatory review of documentation prior to submission for any external agency or customer, as required.
    Interfaces with regulatory agencies as appropriate.

    Responsible for review of customer complaints for reportability to regulatory authorities and reporting to FDA and other regulatory agencies, as appropriate.

    Oversees correction and removal activities.
    Participates in development of Regulatory Strategy documents for new/improved products as required.
    Participates on project teams or sub-teams for the planning of activities needed to meet long term corporate objectives.
    Maintains RA library, Submissions, Changes and documentation in hard copy and electronic files. Creates and maintains a calendar of regulatory applications and renewal dates.
    Provides reports on RA submission progress/activities and various other key tasks to Executive leadership.
    Analyzes available information, exercises sound judgment and makes appropriate decisions in a timely manner.
    Provides supervision to reporting regulatory professionals including assignment of tasks and deadlines, performance appraisals and professional development.
    Tracks by country and product which countries have met regulatory requirements.
    Work with operations to ensure product specifications meet regulatory requirements.

    Monitor and ensure both compliance with and documentation of compliance with Cynosure's policies and procedures as outlined in various Company policies, including the Global Approval Authority Matrix and other mandatory policies pursuant to one's job description.

    Embody and deliver the "Exceptional Everyday"
    Qualifications
    Education

    Specific Area of Study:
    BA/BS in life sciences or engineering
    Experience
    ☒

    12+ years relevant experience in medical device industry and direct regulatory experience
    Skills

    Requires experience with complex regulatory submissions for medical devices (510K, IDE), regulatory experience with active devices with software is strongly preferred.

    Experience with international device regulations required.
    Requires initiative, creative, problem-solving ability and superior oral and written presentation skills.
    Demonstrated project management experience.
    Regulatory Affairs Certification preferred.

    Ability to develop and maintain positive relationships with domestic and international contacts working in regulatory capacities within the government and other organizations.

    Demonstrated successful experience in registering medical devices in US and internationally and managing Regulatory Affairs function within medical device industry.

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

    #J-18808-Ljbffr
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