R&d Manager

3 weeks ago

Toronto, Canada Mira Full time

**About Mira**

Hi, we are Mira Fertility. Our superstar product, the Mira Analyzer, is a leader on the fertility tracking on the market, designed by scientists to help couples and individuals conceive. We started our company to help women and individuals reach their parenthood dreams and make their fertility journey smoother. At Mira, we empower people with the best technology, information, and science to help people reach their fertility goals.

We are actively working with scientists and experts to reach more people—especially because we women and individuals face fertility challenges when they want to start their conception journey. The lack of awareness and information about fertility brings a lot of unnecessary guesswork and stress to those trying to conceive.

We are committed to helping our customers achieve the highest possible success rates and outcomes; that is why our focus is on personalized care, the use of the most cutting-edge technology, and science-backed data.

**About the position**

If want to challenge yourself at a high-growth startup and make a difference in women's health please join us

**Responsibilities**
- Develop and execute development strategies that are aligned with our product development goals and the broader field of in lateral flow immunoassay development.
- Be very familiar with and lead the medical device design control process. Audit and design the studies and study protocols draw conclusions based on the study results, and draft documentation for the design control process that is compliant with the FDA regulations.
- Design and implement research studies, including developing study protocols that adhere to ethical standards and scientific rigor.
- Conduct research, including analyzing data and interpreting results.
- Collaborate with cross-functional teams to drive the development of new products and services.
- Stay up to date with the latest research trends and developments in the field of in vitro diagnostic bioassay development.
- Lead development projects from conception to completion, including coordinating research team activities and ensuring project timelines are met.
- Ensure the quality and integrity of the data used in research projects, including developing and implementing quality control procedures.

**Qualifications**
- Ph.D. in a relevant field, such as biochemistry, biotechnology, or a related field.
- At least 5 years of experience in research methodology, data analysis, and project management, with a focus on in vitro diagnostic bioassay development.
- Extensive experience working with design control process and FDA registration process.
- Extensive experience creating R&D documents for the design control process.
- Proficiency in statistical software, and experience with data analysis and database management systems.
- Excellent written and verbal communication skills, including the ability to present complex scientific concepts to both technical and non-technical audiences.
- The ability to work collaboratively with cross-functional teams, including marketing, sales, engineers, and clinicians.
- Expertise in lateral flow immunoassay development, including knowledge of current research trends, issues, and challenges.
- A strong commitment to ethical standards in research, including the protection of patient privacy and compliance with applicable laws and regulations.

**Details**

The role is a remote position, with a part-time to full-time transition, flexible working hours but with some overlap with US working hours and China.

**What we offer**
- You will work with a dedicated, highly-engaged, international team of professionals who are passionate about helping couples and individuals start their families
- We have a fast paced and collaborative work environment where we encourage open communication, ownership and independence
- In addition to competitive salary we offer performance-based bonus system based on OKR
- Benefits: paid vacation, holidays, and sick leaves,
- We provide professional development opportunities - training courses, workshops and seminars

**Recruiting process**

**Step 1** ‘Screening call with HR’ - **Step 2 ‘Interview with CTO” - Step 3** ‘Assessment task’ - **Step 4** ‘Final interview with CEO ’

**Job Type**: Part-time
Part-time hours: 15 per week

Pay: $4,000.00-$5,000.00 per month

Application question(s):

- Have you had any experience in designing study protocols?
- Have you filed 510k submissions before?
- How many years of experience in research methodology, data analysis, and project management, with a focus on in vitro diagnostic bioassay development do you have?
- How many years of experience creating R&D documents do you have?

**Education**:

- Doctoral Degree (preferred)

Application deadline: 2023-09-30

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