Regulatory Documentation Specialist
1 week ago
Celegence LLC is a renowned consulting firm with offices in Chicago, IL, the U.K., and Bangalore. Our team of experts provides top-notch services to clients across the globe, ensuring regulatory compliance in the life sciences industry.
Job OverviewWe are seeking an experienced Regulatory Documentation Specialist to join our dynamic team. This role involves creating high-quality regulatory documents, such as Technical files, GSPRs, Gap Assessments, and Risk management documentation, compliant with MDR and IVDR regulations.
Responsibilities- Develop and deliver regulatory documents on time, meeting the highest quality standards.
- Collaborate with internal stakeholders, including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs teams.
- Create customized solutions for clients, tailored to their requirements in terms of language, content, format, and presentation.
- Assist the Team Lead/Manager in developing schedules to ensure timely delivery.
- Manage timelines, communicate with team members, and maintain awareness of expectations, milestones, and deliverables.
- Train and mentor junior team members on technical/process-related aspects.
- Minimum 3 years of experience in Medical Device Regulatory documentation.
- Thorough understanding of Gap assessment of Technical file, Gap assessments for PMS, QMS, Harmonized standards.
- Hands-on experience on Technical file, PMS, QMS, Harmonized standards document remediation.
- Strong verbal and written communication skills.
- Able to work as part of a team and possess a constant zeal towards learning and skill development.
- Mentoring skills to act as trainer/mentor for junior members of the team.
- Bachelor's Degree/Post Graduation in any relevant Life Sciences field. Master's Degree is preferred.
- Familiarity with the Life Sciences Industry, preferably Regulatory Services.
- Proficiency with Microsoft Office (Word, Excel, and Outlook).
- Knowledge of Medical Devices Directive (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, (EU) 2017/745 (MDR), (EU) 2017/746 (IVDR).
- An estimated salary range of $80,000 - $110,000 per year, depending on experience.
- A competitive benefits package, including health insurance, retirement plan, and paid time off.
- The opportunity to work with a talented team of professionals in the life sciences industry.
- Ongoing training and development opportunities to enhance your skills and knowledge.
If you are a motivated and experienced professional looking to take your career to the next level, please submit your resume and cover letter for consideration.
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