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Lead Specialist in Regulatory Compliance
2 months ago
Lead Specialist in Regulatory Compliance
At ACON Laboratories, we are dedicated to enhancing healthcare through innovative medical devices that assist in diagnosing various health conditions. Our mission is to optimize processes and reduce expenses for both healthcare providers and patients. Join our team to contribute to the advancement of cutting-edge technologies that improve quality of life.
The Lead Specialist in Regulatory Compliance will oversee the collection of technical data and prepare submissions for in vitro diagnostic and medical device approvals to relevant regulatory bodies. This role will also manage clinical trial studies, including coordinating offsite locations as necessary.
Key Responsibilities
· Oversee the submission and evaluation of documents for inclusion in Design History files.
· Draft, revise, and compile technical documentation and design dossiers in support of CE mark and UKCA mark regulatory submissions.
· Prepare reports for post-market product surveillance.
· Generate EU/UK vigilance reports as required.
- Prepare regulatory submissions for FDA A2F.
- Assist with the registration/application of Class II & III Medical Device Licenses in Health Canada.
- Research guidance documents from FDA, CMDR, MDR, IVDR, and UK MDR2002 for regulatory compliance.
- Review labeling, package inserts, advertising materials, and company website to ensure adherence to FDA and CE regulations.
- Maintain, track, and update regulatory documentation.
- Ensure Essential Requirements Checklists are maintained and updated with applicable standards.
- Provide Technical Documentation to Competent Authorities and Notified Bodies.
- Support OEM customers in achieving CE mark for their products.
Qualifications and Experience
· Bachelor’s degree in a relevant field or equivalent experience.
· A minimum of 6-7 years of experience in the IVD industry, with at least 3 years focused on the preparation and submission of 510k or CE technical files for IVD devices.
Essential Skills and Competencies
· Comprehensive understanding of medical device regulations and terminology.
· Exceptional written and verbal communication skills, with strong technical writing and editing capabilities.
· Ability to produce clear and concise technical documentation.
· Capacity to concentrate in a fast-paced environment.
· Proficient in data analysis and summarization.
· Skilled in Microsoft Office applications.
· Capable of managing and prioritizing multiple projects effectively.
· Ability to follow both written and verbal instructions with precision.
· Team-oriented with a collaborative approach.
· Knowledgeable in QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.
As a member of ACON Laboratories, you will benefit from competitive compensation and a supportive team environment. We encourage qualified candidates to explore a career with us by submitting their resumes.
