Description
Job Description:
- Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field) - in particular from a Services Standpoint.
- Review development quality reports and plans to ensure that the information required for submissions is adequate
- Advises product design teams on regulatory strategy and requirements for specific new products/solutions
- Responsible for regulatory assessments and planning for new product introductions and product changes, and assist in maintaining regulatory compliance
- Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations. Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions
- Reviews and validates marketing and labeling materials
To succeed in this role, you should have the following skills and experience
- Technical/Scientific degree or comparable educational background
- 8+ years of experience in medical device Regulatory Affairs and Quality including Regulatory assessment experience
- Demonstrated experience in similar regulatory roles.
- Familiar with International Regulations, Standards and Quality System requirements.
- Ability to multi-task and take firm positions on technical issues when necessary to ensure compliance is maintained
- Extensive Medical Product knowledge required
- Strong English written and oral communications skills
- High reliability and quality focus