As a core member on product development teams, the Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives. Create detailed written regulatory plans that can be used to target domestic and international shipment dates. Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations. Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance. Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Additionally, the Regulatory Specialist will:
- Communicate application progress to internal stakeholders
- Collaborate with worldwide colleagues regarding license renewals and updates
- Maintain regulatory files and tracking databases as required
- Communicate with regulatory agencies as needed
- Mentor other regulatory affairs personnel
- Bachelor’s degree (Master’s preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- RAPs RAC strongly preferred. ASQ certifications also desirable.
- Minimum of 5 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II or class III, etc.).
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards.
- Must have personal experience with successful preparation and submission of 510(k) submissions.
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
- Proficient knowledge of domestic and international standards
- Strong background in Design Controls.
- Experience in supporting international registrations and/or clinical investigations.
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
- Proficient computer skills in Microsoft Office.
- Understand LEAN concepts, methodologies and deployment.
- May require 5% travel annually with possibly some international.
SKILLS AND CERTIFICATIONS
Medical Device background
I look forward to hearing from you
APN Software Services, Inc .
39899 Balentine Drive, Suite 385, Newark, CA 94560 .
Direct: 510.623.5049 | Fax: 510.623.5055 | Email: firstname.lastname@example.org