Role Specification: Class III Product Specialist
(Contractor - Galway)
Position Overview:
We are seeking a skilled and experienced Class III Product Specialist to join our clients team on a contractor basis in Galway. The role will require a candidate who is highly proficient in working with Class III medical devices, specifically with combination product experience being highly desirable. This individual will collaborate closely with Operations, provide Regulatory Affairs (RA) support, and be involved in writing assessments and submissions, particularly for 30-day notifications (30DN), while also contributing to sustaining projects.
Key Responsibilities:
Collaboration with Operations on Changes:
1. Work with the Operations team to ensure that any product changes related to Class III products are well managed and documented in accordance with relevant regulatory requirements.
2. Assist in implementing change controls, ensuring compliance with regulatory standards and timelines.
Regulatory Affairs Support:
1. Provide RA support for Class III products within the portfolio.
2. Help manage regulatory documentation and assist with maintaining product files and records.
3. Support in the preparation and submission of regulatory filings as necessary.
Writing Assessments:
1. Perform thorough product assessments, ensuring they meet regulatory standards and internal requirements.
2. Write clear and comprehensive assessments for Class III products, focusing on compliance, safety, and performance.
Writing Submissions (30DN):
1. Prepare and submit regulatory documents, with a focus on 30-day notifications (30DN).
2. Ensure that all submissions are accurate, complete, and adhere to the required timelines.
Sustaining Projects:
1. Work on sustaining projects related to Class III products, ensuring continuous product lifecycle management.
2. Implement corrective and preventive actions (CAPA) as required to maintain product compliance and quality.
Desired Experience:
1. Experience with Class III products is essential.
2. Combination product experience is highly desirable.
3. Proven experience in Regulatory Affairs and operations within the medical device industry, especially in relation to Class III products.
4. Strong background in writing regulatory assessments and submissions, particularly for 30DN.
5. Experience in change management processes within a regulated environment.
6. Familiarity with sustaining projects, including product lifecycle management and CAPA.
Skills and Attributes:
1. Level 8 degree
2. 1-2 years experience
3. Excellent written communication skills with the ability to draft clear and concise regulatory documents.
4. Strong attention to detail, ensuring accuracy in all submissions and assessments.
5. Ability to work independently and as part of a cross-functional team.
6. Ability to manage multiple priorities and deadlines effectively.
7. Knowledge of ISO 13485, FDA regulations, and other relevant regulatory guidelines.
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