石家庄招聘

Roles and Responsibilities:
? Manage all regulatory affairs project of the company including company/business restructure, manufacture site change, product localization, company integration and local sourcing to ensure compliance with government requirement and company standard.
? Negotiate and supervise all projects with government and related 3rd party and regulatory consultant (whenever applicable).
? Partnership with registration related clinical trial project in the country and cooperation with the Clinical Research Director.
? Develop and maintain good and professional relationship with the regulatory authorities, legislators, trade association, key opinion leaders to ensure smooth and efficient project process and influence for positive change of regulatory environment.
? Interface with corporate management team in order to ensure regulatory strategies and processes are in line with local business strategy.


Requirements:
? University Degree in life sciences or medical background.
? 8+ years of relevant working experience & solid knowledge on regulatory, quality and compliance field.
? Have a strong understanding for the regulatory environment for medical device in China.
? Proven ability to develop and execute a regulatory strategy and project plan to achieve destination in the reliable timeframe.
? Bilingual in English and Chinese (Mandarin) both spoken and written, any other language is an advantage.


Personal / Leadership Competencies
? Strong result orientation in order to achieve rapid and sustainable growth.
? Energetic and self-initiative.
? Strong Project management, process skills.
? Planning and organization skills.
? Proven ability to lead, decide and execute in a fast-growing business environment.
? Excellent written and verbal communication and negotiation skills.
? Strong influential skills and relationship building ability.
? Able to work under pressure and meet tight timelines.

Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.
 
We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
?    Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
?    Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
?    Sports Medicine - minimally invasive surgery of the joint
?    Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .