成都招聘

Regulatory Affairs Manager,China

中国区注册事务经理

Role Summary/Purpose

The Regulatory Affairs (RA) Manager Product provides subject matter expertise. He/she works within a team of Regulatory Affairs professionals to ensure Andala establishes best practices in the area of premarket regulatory submissions and new product development.

Responsibilities

File / maintain regulatory deliverables

Actively participate as team member on all assigned new product introductions.

Create regulatory compliance / project plan using Regulatory Intelligence and in collaboration with Region RA to ensure all requirements are met for country submissions; work with relevant personnel to ensure appropriate, timely input is provided for submissions.

Create and file submissions; communicate with authorities regarding these submissions.

If specific country testing is needed, work with Region RA, and arrange for test devices and support as needed.

Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.

Review changes in existing products to determine need for new/revised submissions or document reason for no submission

Educate, train, & advise company professionals to ensure compliance with regulatory requirements

Communicate changes in existing products to Region RA representatives for determination of the need for new/revised licenses or registrations.

Partner with Region RA representative for countries with license expiration requirements, to establish plan and deliverables for timely submission for renewal of license.

Identify any clinical data requirements for product licensing globally and insure the requirements are documented in the compliance plan.

Provide RA oversight to clinical studies.

Support regulatory inspections as required.

Establish and maintain good relationship and friendship with related authorities and experts.

Qualifications/Requirements

Bachelor’s Degree (or internationally recognized equivalent) & minimum of 5 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration

Ability to prioritize, plan & evaluate deliverables to established strategic goals.

Proven application of analytical skills in a regulatory environment

Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.

Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.

Strong problem solving and negotiation skills

Ability to work well independently & in a team setting.

Prior experience using spreadsheet and presentation software.

Must be willing to travel up to 10% of time.

Desired Characteristics

Advanced degree in scientific, technology or legal disciplines.

Regulatory Affairs Certification (RAPS).

Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

Knowledge of Quality Management Systems (QMS)

Experience with working across cultures/countries/sites

Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on Andala regulatory strategies.

Andala Co. Ltd. is a well-known company with years of development in China. Its sales turnover and profit always rank at top in the Industry.

Guangzhou Andala Co. Ltd. aims at providing the efficient solution for supply chain with business in technology, FMCG, retailing, fashion, medicine, automotive, chemicals, aviation Industry and other industrial sectors. Headquarter of Guangzhou Andala Co. Ltd. locates in Guangzhou with branches in Shanghai and Beijing. The Company is trying to provide the most efficient one-stop service for the customers. We are committed to become a first-class multinational group.

Guangzhou Andala Co. Ltd. establishes a business network in many cities in China. With good reputation, Guangzhou Andala Co. Ltd. has been widely recognized and praised with its excellent service and continuously improved management systems. We will do all means to respect, take care of and motivate our staff to create an enjoyable environment.

As our business is expanding quickly now, we sincerely invite competent and self-motivated individuals to join our team. We offer attractive remuneration package and career development opportunities to successful candidates. Candidates please send your applications with detail resume both in Chinese and English, recent photo, expected salary and contact number to our designated email address: hrjob88@foxmail.com
有意者请将个人简历发至邮箱：hrjob88@foxmail.com,谢谢合作!应聘资料将予保密。