Santa Ana, California
about 1 month ago
Principal Affairs Regulatory Specialist
Santa Ana, CA
Job Id: 11144
Are you looking to make a career change to rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package medical insurance, dental insurance, vision insurance, and 401K. Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Maintain regulatory files.
- Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, etc.
- Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
- Support approval in other regions as required.
- Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.
- Assess device related complaints for medical device reporting requirements. C
- Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required.
- Review and approve complaint files.
- Review product labels and review promotional material for compliance with applicable regulations and technical standards.
- Maintain product UDI listings in country-specific databases.
- Bachelor's Degree with 10 years’ experience or Master’s Degree with 8 years’ experience or PhD Degree with 6 years’ experience in regulatory affairs and/or related departments within the IVD medical device industry
- Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.)
- Scientific knowledge must be able to digest complex data while keeping the big picture through good analytical skills.
- Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
- Proactive, high performance result oriented and manage projects with ethical integrity.
- Technical system skills (e.g. MS office applications, databases, efficient online research).
- Manage multiple projects and deadlines
- Medical Insurance.
- Dental Insurance.
- Vision Insurance.
- Direct Hire.
Ask for: Tasha Harper
Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.