Specialist in Regulatory Affairs (RA)
We are looking for an ambitious and detailed oriented individual to join our regulatory team.
The regulatory team is responsible for the compliance with applicable law and regulations relating to medical device manufacturers in Nox Medical‘s market areas, including but not limiting to United States, Canada, Europe, Japan, China, Australia and South- Korea.
- B.Sc. / M.Sc. degree in related field or equivalent experience required
- 3+ years of relevant experience
- Knowledge of national and international regulatory requirements, and compliance programs relating to medical devices
- Experience with regulatory affairs, submissions, compliance program and quality systems
- Good planning/ organizational skills and techniques.
- Developing problem solving skills
- Exercise judgment within defined procedures and practices to determine appropriate action
- General knowledge of ISO 13485:2016
- Excellent oral and written communication skills to support good interact with regulatory agencies
- Good negotiation and diplomatic skills
- Excellent English skills, both verbal and written
Function & Responsibilities
- Participates in design and development projects as a member of a cross-functional team
- Prepares/contributes to preparation of regulatory documents for medical device submissions
- Compiles technical documentation data packets for distributors to support international product registration
- Communicates with regulatory agencies in support of regulatory submissions
- Coordinates timely renewal of certificates, licenses, and registrations
- Participates in developing and implementing the necessary procedures to ensure the companies ongoing compliance with national and international regulations/requirements
- Participates in improvements projects related to the Quality Management System
- Research applicable national and international standards to ensure the company’s ongoing compliance
All applications shall be sent to email@example.com before June 25th 2018. More information about the position can be found with Kolbrun E. Ottosdottir, firstname.lastname@example.org. All inquiries and applications will be treated with utmost confidentiality.