Sr. Regulatory Engineer
In this role, you have the opportunity to
- Provide appropriate global regulatory strategy and planning for new product introductions and product change; ensure timely and well-organized registrations activities; Provide guidance on risk assessment, clinical evaluation and required corrective actions to meet regulatory requirements.
You are responsible for
- Responsible for implementing regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
- Advice product design teams on regulatory strategy and requirements for specific new products/solutions.
- Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
- Support development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and Product registrations.
- Create, review and validate marketing and labeling materials while supporting projects and other key regulatory initiatives
- Develop and facilitate regulatory submissions, for new products/solutions, existing products/solutions.
You are a part of
- Professional Regulatory Team, with around 10+ team peers globally.
To succeed in this role, you should have the following skills and experience
- BS+ in science, engineer or regulatory affairs.
- Minimum of 5 years’ experience in active medical device regulatory affaire role;
- Be skillful in EU MDD/MDR, FDA and China NMPA registration is required.
- Be familiar with global regulation requirements.
- Proficient in English and Chinese communication including reading, writing, speaking and listening.
- Require strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
- High efficiency on problems solving from RA perspective.
- Capable of handling pressures during working.
- Willing to communicate and cooperate with cross function team members.
- Strong ability in organizing CFT to finish tasks on time;
- Willing to take ownership and capable of delivering fast.
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