- 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.
- 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.
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Sr Manager, International Regulatory Affairs - Shanghai, 中国 - Hydrafacial Trading (Shanghai) Co Ltd (China)
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描述
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:
HERE'S WHAT YOU'LL BRING TO THE ROLE:
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.
