Location: Andover MA
Duration: 6 Months
As a core member of multiple new product development teams, the Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
1. 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.
2. Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
3. Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
4. Review and approve advertising, promotional items and labeling for regulatory compliance.
5. 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 within MCS
• Bachelor’s degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
• Minimum 3 years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
• 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
• Experience with FDA 510(k) submissions
• RAPs RAC strongly preferred
• Understand LEAN concepts, methodologies and deployment
• Proficient computer skills in Microsoft Office