RA Manager
6 months ago
Description
:HERE'S WHAT YOU'LL BE DOING:
The RA Manager - APAC enables the business in identifying and implementing efficient, time effective, legal solutions for regulatory topics. The role is accountable to ensure legal compliance while finding solutions that support business growth. The role educates and communicates to all stakeholders the requirements, the process, risks, and progress for all regulatory submissions.HERE'S WHAT YOU'LL BRING TO THE ROLE:
Strategic Role Responsibilities
Maintain current knowledge of CFDA and international regulation, guidance and standards applicable to company products understands best practice and monitors competitors’ movements Monitor and manage APAC and China regulation guidelines and the impact of changing/evolving regulations on country registrations, and license renewals and communicate to management to ensure timelines are met. Oversee new product development and existing timelines in preparation of regulatory documentation for consumables and devices including labeling/artwork and any documentation submission support as it relates to the maintenance of existing licenses. Provide regular updates on APAC and China to regulatory management and business development teams. Provide input and adhere to scheduling and management of Post Market Surveillance (PMS) plans and reports. Review and manage the essential requirements checklist for accuracy and update regularly. Maintains and manages awareness around new and developing legislation, regulatory policy changes and technical guidance related to the consumables and devices and communicates to regulatory management. Review consumable formulas for regulatory compliance regularly. Review Invoices for accuracy and confirm with management. Review and complete change evaluation forms (CEFs) relating to APAC/China Review for accuracy and provide declaration of conformity documents for the APAC/China regions when required. Communicate and work closely with domestic and international regulatory teams for alignment and support. Other duties as assigned by management.Operational Role Responsibilities
Regulatory filings (new/ updates):Sets up efficient internal and external facing processes.Timely compile materials for license renewals, updates, and registrations, leveraging global and local partners, distributors and consultants.Files and then monitors submissions, anticipates issues and creates proactive plan of action/responses. Manages product changes for impact on regulatory filings. Provides Regulatory support for Fujia (Contract Manufacturer) in China when necessary. Engages cross-functional stakeholders pro-actively to communicate regulatory requirements to assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions. Communicates APAC/China regulatory requirements and challenges effectively to meet project needs. Communicate any in country testing requirements and units requested as a result. Review marketing material for regulatory compliance Review labeling and labels for compliance with regulatory requirements Provide the regulatory reviews of customer complaints and define the regulatory reportability. Establish and maintain system for tracking changes in documents submitted to agencies or partners in APAC. Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management as required. Works closely with international and global Quality partners to ensure daily guidance to local Quality employees is given in full alignmentPeople & Leadership Responsibilities
Participates actively in local and U.S. market cross-functional teams Is an active team member of the APAC Regulatory Team Guides, coaches and manages regulatory/quality employees towards achieving functional and organizational goalsFunctional Expertise
Knowledge of medical device and cosmetic regulatory requirements in APAC Strong understanding of design controls To ensure the Registration / ESF Tracker and regulatory tracker is maintained, accurate and updated regularly. Maintain data and regulatory files in the regulatory folders to ensure compliant documents are stored. Requires proficiency with standard software (Word, Excel, PowerPoint, etc.)Soft Skills
Excellent verbal and written communication skills are essential. Ability to manage multiple priorities Requires creative, problem-solving ability and oral and written presentation skills Team oriented, the ability to work in a 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 The ability to meet deadlines and be detailed orientated is necessary.Qualifications
Bachelor’s degree required Specific Area of Study: BS or BA in engineering or scientific fieldExperience
5 to 8 years relevant experience Specific Related Experience: the quality/clinical/regulatory discipline Experience with electromechanical and/or software devices is a plusWhat else can you expect with Hydrafacial?
Every person here is a key player in our success. We are firm believers in making the little things count each day so that the big things will follow. If this sounds like you, come check us out This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
We mean it when we say you’ll LOVE this role.
BeautyHealth is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities.
BeautyHealth does not accept unsolicited assistance or resumes/CVs from third party search firms. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral or CV/resume submitted by a search firm to any employee at our company without a valid written search agreement. If we need additional support, we will be sure to reach out directly to one of our preferred providers.Please no phone calls or emails
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