Regulatory Affairs Specialist
Th Regulatory Affairs Specialist performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry and maintenance.
The candidate will:
- Prepares robust regulatory applications to achieve departmental and organization objectives;510k’s, Global Registrations / Submissions, Audit Support – FDA and Notified Body, UDI management, and MDR management.
- Creates, reviews and approves change orders as required.
- Act as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA and other worldwide regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission database and file systems.
- Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
- Support interactions with FDA and other regulatory agencies.
- Supports the product release process by creating or reviewing and approving requests for product release.
- Reviews protocols and reports to support regulatory submissions.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
The candidate must possess:
- BA or BS degree, technical discipline preferred.
- Experience in the Medical Device Industry (Spine or Orthopedics preferred).
- Minimum 5 years of experience, including a minimum of three years regulatory experience.Experience with ISO 13485:2016 and MDSAP implementation preferred.
- Experience with 510(k) submissions and US device regulations.
- Experience with EU and other international medical device regulations and submissions.
- Ability to work in a fast-paced startup business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Experience working in a broader enterprise/cross-division business unit model.
How to Apply:
If you are the next Regulatory Affairs Specialist and would like to join our dynamic team here at Titan Spine, Inc., please send your cover letter, resume and salary requirements to: HR@Titanspine.com.
The Designer/Drafter is responsible to apply knowledge of mechanical drafting and design principles, practices, and procedures to assist the design and development of new or improved medical devices (e.g. instruments and implants). The Designer/Drafter will assist, under the direction of Product Development Engineers, in the design of new products using the company’s design control procedure. The Designer/Drafter will also be responsible for maintaining compliance to industry and regulatory guidelines and standards when creating documents included in the Design History File.
The candidate will:
- Carry out drafting and design assignments such as CADD models, assemblies, drawings, and specification documents consistent with industry standards and guidelines (e.g. ANSI 14.5, ISO 9000, ISO 13485), GMP documentation, and common mechanical design practices.
- Create part, assembly, sub-assembly, and detail level models and drawings based on concepts and ideas from the Product Development Engineers.
- Complete and maintain compliance with document/design control procedures. Participate in Document Change Record forms as means of documenting and controlling changes to product design and specifications.
- In the conduct of drafting and design activities, completion of additional activities such as, but not limited to, drawing checking, tolerance analysis, Geometric Dimensioning and Tolerancing (GD&T), model analysis and parametric link, and control and compilation of drawings where parametric link integrity and revision control is maintained. Provide insights and recommendations about Design for Manufacturability (DFM) and Design Failure Mode Effects Analysis (dFMEA).
- Assist in the development of best practices about the creation of models, assemblies, drawings, and specification documentation at Titan Spine.
- Participate in the implementation and management of a product data management software (e.g. SolidWorks PDM). Manage CAD data created within the Design Control system at Titan Spine.
- Other duties in support of Product Development, R&D, Operations, and general business operations may be assigned as resource needs require.
- Other duties as assigned by Executive Management.
The candidate must possess:
- Qualified candidates may possess an A.S or B.S. or Technical degree in Design or Drafting, or equivalent experience at the discretion of the Dir. of Product Development Engineering. The position also requires three to five years of experience in design and drafting.
- Have individual skills and abilities in the following areas:
- Advanced mechanical/mechanism design and drafting capabilities.
- Proficient use of Computer Aided Engineering/Design (CAE/CAD), proficiency with SolidWorks is preferred. Experience and understanding of parametric link and revision control.
- Ability to complete tolerance stack analysis on complex assemblies and incorporate GD&T accordingly.
- Understanding of modern manufacturing techniques including 3D milling, turning, wire-EDM, and welding. Prior experience with Design for Manufacturability (DFM) and ability to provide recommendations. Ability to operate and interface directly with engineering and manufacturing resources.
- Good communication skills, verbal and written, with project engineers on status of requests. Ability to prioritize and handle multiple tasks. Ability to work individually and in a team.
- Attention to details and ability to review own work for clarity and completeness. Ability to hold yourself accountable about the quality of work. Ability to meet deadline with focus on quality and customer service.
- Experience in a highly regulated environment is desirable, preferably in the medical devices industry.
- Experience with the Microsoft Office Suite (e.g. Outlook, Word, Excel).
- Experience with Product Lifecycle Management software is preferred (e.g. SolidWorks PDM, PTC Windchill).
- Familiarity with ISO 9000, CAPA, PV, FMEA, Six Sigma and Lean practices is preferred.
- Familiarity with Finite Element Analysis (FEA) including set-up and data interpretation would be nice to have (optional).
How to Apply:
If you are the next Designer/Drafter and would like to join our dynamic team here at Titan Spine, Inc., please send your cover letter, resume and salary requirements to: HR@Titanspine.com.