Sr Manager, International Regulatory Affairs

7 months ago


Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full time

Description

:

Hydrafacial is hiring a Sr. Manager, International Regulatory Affairs, who is a key contributor in bringing the company’s products into new markets and spearheading global medical device/cosmetic regulatory submissions. Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions, including labeling review.

HERE’S WHAT YOU’LL BE DOING:

Lead all regulatory affairs transactions within region. Assist with the development of regulatory processes to support the region and all other regulatory submissions, approvals, and inspections. Work on multi-functional team to determine the correct regulatory strategy in each market the company operates in. Oversight of the preparation and filing of regulatory documents with the FDA and international regulatory bodies; setting the standards for and reviewing all submissions to assure adequacy and accuracy. Communication with representatives of foreign regulatory agencies as needed to advance projects. Manage global trade compliance to support customs clearances. Work closely with internal and external clinical affairs experts to review clinical study protocol and management of studies to support regulatory submissions, data integrity and promotional claims. Keep abreast of changes in the global regulatory regulation landscape and communicate those changes to all stakeholders. Additional duties as assigned by management.

HERE’S WHAT YOU’LL BRING TO THE ROLE:

8+ years of combined regulatory affairs experience in the medical device industry, both domestically and internationally. Experience in all regulatory processes and regulations in APAC and EMEA market. Cosmetics experience is a plus. Medical device and quality disciplines required. Bachelor’s degree; preferably in a scientific or engineering discipline. Experience with requirements for international product registration. Ability to both understand and write technical documentation is required. Good command in English is fundamental.

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. 



  • Shanghai, China International Flavors & Fragrances Full time

    Job Description Summary Are you passionate about Regulatory Affairs? Would you love to work for a global organization that is “Doing More Good” for people and planet? Joining science and creativity, we are an international collective of thinkers who partner with customers to bring scents, tastes, experiences, ingredients, healthy and...


  • Shanghai, China 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: The Impact You’ll Make in this Role As a Regulatory Affairs...


  • Shanghai, China Abbott Full time

    EXPERIENCE: Over 5 years working experience in regulatory affairs for pharmaceuticals including more than 3 years in the project management post; Solid registration project management skills; Effective problem solving and planning capabilities; Good knowledge of CFDA regulations and guidelines; Good working relationship with regulatory authorities; ...


  • Shanghai, China L'Oréal Full time

    Manage APAC regulatory compliance projects on both cosmetic ingredient and finished product to support R&I innovations. Develop robust compliance solutions with cosmetic, chemical and other possible related area regulatory expertise, risk assessment and recommendation, to both upstream and downstream innovation projects led by APAC R&I hubs and coming to...


  • Shanghai, China Abbott Full time

    Major Responsibilities/Activities: Provide regulatory input to supervisor for decision making on registration filing strategies. Set up product registration timeline and ensure well implement. Prepare and validate registration dossier to ensure fully meet Chinese regulations and guildlines. Track on-going projects and handle technical issues from...


  • Shanghai, China MAHLE Full time

    Your Roles & Responsibilities Develop and maintain strong relationships and communications with designated local government organizations in China. Support on political and regulatory analysis, provide development & impact analysis for senior management and internal relevant departments; Maintain and continuously improve company’s position and...

  • Regulatory Officer.

    6 months ago


    Shanghai, China PSI Full time

    Job Description Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. Office-based in Shanghai Office Your role: REGULATORY INTELLIGENCE Monitor new...


  • Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full time

    Joinus in pioneering breakthroughs in healthcare. For everyone. Everywhere.Sustainably. Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique...


  • Shanghai, China INVISTA Full time

    Your Job The GPA (Government and Public Affairs) Specialist plays a critical role in supporting INVISTA’s government and public affairs initiatives. The specialist will be responsible for managing relationships with government officials, implementing government relations strategies, developing and executing public affairs strategies, managing...


  • Shanghai, China Siemens Healthineers Ltd. Full time

    Do you want to join us in helping to fight diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.  Your...


  • Shanghai, China SR Technics Group Full time

    We are a world leading Engine MRO service provider, headquartered in Zurich, Switzerland, with over 90 years of operational experience. Our unwavering dedication to innovation, excellence and environmental responsibility propels us forward on our journey to becoming the leading, most customer-centric, and sustainable Engine focused MRO worldwide.   Working...


  • Shanghai, China Amazon (Shanghai) International Trading Company Limited Full time

    Amazon Global Selling has been helping individuals and businesses increase sales and reach new customers around the globe. Today, more than 50% of Amazon’s total unit sales come from third-party selection. The Global Selling team in China is responsible for recruiting local businesses to sell on Amazon’s overseas marketplaces, and supporting local...


  • Shanghai, China Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Job Description At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough...


  • Shanghai, China Roche Full time

    The Position Job Summary : Lead medical scientific affairs function, ensure its management of the affiliate adhering to the highest scientific and ethical standards and fulfilling all regulatory requirements. This position provides strategic directions and contributes to the collective medical management of the company and to the appropriate...


  • Shanghai, China Bayer Full time

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Shanghai, China Werfen Full time

    Overview Post Date May 10, Number WEBCN-- Job Function Other Location 上海 Country Mainland China About the Position Responsibilities : • Builds and maintains smooth communication channels with local government departments (provincial Healthcare Security Administration and Health Commission etc.) and associations in relevant fields. •...


  • Shanghai, China IQVIA Full time

    Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and...


  • Shanghai, China Medtronic Full time

    Careers that Change Lives A Day in the Life Responsibilities may include the following and other duties may be assigned. Maintains a deep understanding of the science behind our products. Develops competitive intelligence in our product space. Drives education and outreach for safe and effective use of our products. Develops, implements and...


  • Shanghai, China Caidya Full time

    Job Overview: The Senior Medical and Regulatory Writer works independently to prepare and deliver clinical and regulatory documents for a wide range of therapeutic areas, performing the tasks listed below. Job Duties and Responsibilities: Write, edit, format, compile and review assigned documents requested by internal cross-functional teams and/or...


  • Shanghai, China Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. The Associate Director of Corporate Affairs (CA) for Alzheimer's disease will play a crucial role in supporting both the development and implementation of international strategies to improve the detection, diagnosis, and care of Alzheimer's disease. Through a...