Benefits Offered: 401K, Dental, Medical, Vision
Employment Type: Contractor
Are you actively seeking for a new contract Senior Regulatory Affairs Specialist role in the San Diego, CA area? This position is with a major in-vitro diagnostics company and a Bachelors are encouraged to apply. The client focuses on improving the diagnosis of high risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. The individual will support the development and commercialization of its novel biomarker products. If you meet the requirements, please send your resume to firstname.lastname@example.org.
This position will provide support to the Vice President, Clinical & Regulatory Strategy in the implementation of global regulatory strategies for marketed and development products. This individual will lead or support regulatory activities for internal and external programs and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manage, coordinate and review regulatory submission/registrationdocumentation for domestic and international product registrations, including the independent determination of the necessary design documentation (including language/labeling requirements).
- Develop gap and impact assessments of changing global regulatory requirements (e.g., IVDR) and revise or drafts new documentation accordingly.
- Compile regulatory database of regulatory information, labeling and change requirements for international registrations to support market expansion.
- Assure compliance with all applicable (domestic and international) regulations.
- Monitor regulatory trends and be able to apply learnings and provide guidance or strategy related to such trends.
- Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
- Ensure compliance with Company’s Quality Management System.
- Other duties as assigned.
- Degree in a relevant field (BS/MS in engineering or science ideal) with 4+ years relevant MD/IVD regulatory affairs experience (or equivalent combination education and/or work experience in another function with demonstrated transferable skills set dependent on the level of qualifications achieve.
- IVD, clinical diagnostic, CLIA or similar experience is preferred.
- General working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, CMDR, and other worldwide regulatory regulations as appropriate and standards, e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approvaland post-market surveillance of IVDs.
- Highly self-motivated; works on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Exceptional writing skills and verbal interpersonal skills to influence many diverse internal/external customer groups.
- High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
- Ability to work cohesively with multi-disciplinary scientific working groups.
- Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio.
While performing the duties the employee is:
- Constantly required to reach computers and other office equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
- Frequently required to sit
- Frequently required to stand
- Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
- Frequently required to lift and transport items weighing up to 25 lbs.
- May occasionally be required to travel to audits, meetings, tradeshows
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary.