Analyst, Regulatory Affairs

**Ubicación MEXICO, MEXICO CITY**

¿Está buscando una empresa que se preocupe por la vida y la salud de las personas, incluida la suya? Inspiremos vidas más saludables, juntos

**Olympus, una empresa líder en tecnología médica, se ha centrado en mejorar la vida de las personas durante más de 100 años.**

**Nuestro propósito es hacer que la vida de las personas sea más saludable, segura y satisfactoria.**

**Nuestros valores fundamentales se reflejan en todo lo que hacemos**:

- Integridad - Empatía - Agilidad - Unidad - Visión a largo plazo_

Cumplimos con nuestro propósito y nuestros valores fundamentales manteniéndonos **fieles a la vida**

Sr. Regulatory Affairs Specialist will be responsible for assisting in the support of Regulatory Affairs activities, including support of the organization regulatory initiatives and obtaining / maintaining market approval of Olympus medical devices in the markets served by Olympus.

**Job Duties**:
Collaborates with the Regulatory Affairs team and international regulatory colleagues to provide regulatory support for new products/therapies or changes to existing products.
Works with engineers and technical experts to address questions from regulatory agencies. Lead or compile all materials required in submissions and license renewals.
Prepares US and International submissions and work directly with government agencies and/or distributors to obtain product approval/clearance.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations
Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as APAC, Japan, the Far East, Australia, and Latin America
Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team
Supports pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems
Supports review of device labelling and marketing materials for compliance with FDA submissions and applicable regulations
Interfaces directly with FDA and other regulatory agencies
Supports the product release process by reviewing and approving requests for product release
Reviews protocols and reports to support regulatory submissions
Supports coordination and preparation of document packages for regulatory submissions.
Maintain regulatory documentation in accordance with departmental practices and quality system requirements.
Provides support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring RA agency review.
Establishes and maintains good relationship within the RA department, cross functional teams and assists in developing and maintaining positive relationships with internal and external reviewers through oral and written communications.
Supports regulatory compliance activities, including internal or external audits, post-market surveillance activities, etc. as needed.
Perform other duties as necessary and assigned.

**Job Requirements**:

- Education*:_
- B.S. or equivalent degree in science, engineering, or related medical/scientific fields.
- RAC, CQA, and CQM accreditation is a plus.
- Experience*:_
- A minimum of 5 years’ experience or 3 years with Master’s degree in regulatory compliance within Medical Device industry is required.
- A minimum of (2-3) years in a Regulatory Affairs role required Experience with FDA requirements (PMA, 510k, etc.), China requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards.
- Knowledge of ISO 13485 Quality System standard, and other applicable US and international regulations, guidance’s, and standards.

**Skills**:

- Ability to work in small team environment but also self-starter with ability to work independently.
- Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
- Must be able to meet deadlines and be detail oriented.
- Good planning and organization skills a must.
- Strong critical thinking and problem-solving skills.

**¿Por qué unirse a Olympus?**

**_
Aquí, las personas importan: nuestra salud, nuestra felicidad y nuestras vidas._**
- Salarios competitivos, bonificación anual y programas de ahorro con igualación de la empresa
- Cobertura integral médica, dental y de la vista vigente a partir de la fecha de inicio
- Programa de Asistencia al Empleado 24/7
- Clases virtuales gratuitas de bienestar en vivo y bajo demanda
- Apoyo al equilibrio entre la vida laboral y personal con funciones híbridas y remotas
- 12 días vacaciones pagadas llamados Días Olympus, adicionales a