International Regulatory Affairs Specialist

International Regulatory Affairs Specialist

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

We are looking for a Regulatory Affairs Specialist for our client based in Solothurn.

Primary Responsibilities:

- 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 materials
-Assist in development of regulatory processes and work instructions/SOPs and training material for rest of the world submissions
-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
- Support team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
- Assist in obtaining Certificates of Export from FDA, Certificate of Analysis, Apostille, or other applicable import/export notifications as needed
- Support maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
- Assist with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
- Provide assistance in keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to company products and processes (with focus on ChinaMay assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions. 

Must Have:

- Bachelor's (minimum 5 years' experience) or Master's (minimum 3 years) Degree in engineering or life sciences
- 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)
- Language skills in Mandarin and English
- International regulatory experience in China and Japan (Asian registrations)
- RAC accreditation (through RAPS) and/or PMP certification

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!