International Regulatory Affairs Specialist - Medical Devices

My client, a leading Medical Device expert is looking for an International Regulatory Affairs Specialist to expand into Asia Pacific markets.

The International Regulatory Affairs Specialist will support international regulatory affairs activities, including but not limited to:

- Assisting in providing international regulatory expertise to new product development and sustaining engineering team's preparation and submission of regulatory documentation for product registration/licensing in Asia (China) and selected global markets (Japan, Australia, NewZealand)
- Work with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product labeling and marketing material
- Assist in the preparation of global registration dossiers to obtain product registrations in Asia and other markets worldwide
- Participate, as directed, in new product development teams to ensure understanding of global regulatory requirements.
- Assist in obtaining Certificates of Export from FDA, Certificate of Analysis, Apostille, or other applicable import/export notifications as needed

(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)

Must Have:

- Bachelor's (minimum 5 years' experience) or Master's (minimum 3 years) Degree in engineering or life science.
- A Minimum of 2 years of medical device experience with strong understanding of EU and USA regulations
- Experience with ISO 13485, ISO 9001, QSR; experience and strong understanding of Technical Files and Design Dossiers
- Strong Project Management skills required and experience with ERP systems including SAP, Oracle PLMs, Agile, Windchill etc.
- Must be proficient and/or willing to become proficient in Asian product registration processes; China CFDA, Japanese PMDA
- Strong communication skills (verbal and written)
- Proficiency in Microsoft Office (Word, Excel, Powerpoint); OneNote desirable
- Ability to work in team environment, has to be a self-starter with ability to work independently with minimal supervision
- Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors is essential
- Must be able to meet deadlines and be detailed orientated
- Good planning and organization skills are required along with strong critical thinking and problem solving skills
- Willingness to travel up to 10% of the time (domestic and international)

Preferred:

- Master's (minimum 3 years) or Advanced Degree (PhD with 1-2 years of experience) in engineering or life sciences (STEM Background)
- Bilingual skills in Mandarin and English
- International regulatory experience in China and Japan (Asian registrations)
- RAC accreditation (through RAPS) and/or PMP certification

Language proficiencies:

- English spoken and written is a must, German and Mandarin (Chinese) knowledge in addition preferred

Please send CVs or call

Michael Bailey International is acting as an Employment Business in relation to this vacancy.