Lead Manager, International Regulatory Strategy
6 days ago
Position Overview
Hydrafacial Trading (Shanghai) Co Ltd is seeking a Senior Manager for International Regulatory Affairs, a pivotal role in facilitating the entry of our innovative products into diverse global markets while leading the charge on regulatory submissions for medical devices and cosmetics. This position will serve as the primary authority on international regulatory matters for designated projects and regions, including the review of product labeling.
Key Responsibilities:
- Oversee all regulatory affairs activities within the assigned region.
- Contribute to the formulation of regulatory procedures to enhance regional support and ensure successful submissions, approvals, and inspections.
- Collaborate with cross-functional teams to establish effective regulatory strategies tailored to each market.
- Supervise the preparation and submission of regulatory documents to both the FDA and international regulatory authorities, ensuring all submissions meet established standards for quality and accuracy.
- Engage with representatives from foreign regulatory agencies as necessary to facilitate project advancement.
- Manage global trade compliance to ensure seamless customs clearance processes.
- Partner closely with internal and external clinical affairs professionals to evaluate clinical study protocols and oversee studies that support regulatory submissions, data integrity, and promotional claims.
- Stay informed about changes in the global regulatory landscape and relay pertinent updates to all relevant stakeholders.
- Perform additional responsibilities as assigned by management.
Qualifications:
- A minimum of 8 years of regulatory affairs experience within the medical device sector, both domestically and internationally.
- Comprehensive knowledge of regulatory processes and requirements in the APAC and EMEA regions.
- Experience in the cosmetics field is advantageous.
- Strong background in medical device regulations and quality assurance practices.
- Bachelor’s degree in a scientific or engineering discipline is preferred.
- Familiarity with international product registration requirements.
- Proficiency in both understanding and drafting technical documentation is essential.
- Excellent command of the English language is required.
At Hydrafacial, every team member plays a crucial role in our collective success. We believe in the significance of daily contributions that lead to substantial achievements. If you are looking for an opportunity to collaborate with industry leaders while gaining invaluable global and strategic experience, we encourage you to consider this role.
Commitment to Diversity:
Hydrafacial is dedicated to being an equal opportunity employer. We strictly prohibit discrimination and harassment of any kind based on race, gender, religion, sexual orientation, national origin, gender identity, age, disability, genetic information, pregnancy, or any other protected characteristic as defined by applicable laws. We are committed to working with and providing accommodations to applicants with physical and mental disabilities.
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