Quality Assurance/Regulatory Affairs Associate (25-Week Opportunity)

Diva International Inc. (“DIVA”) is looking for a Quality Assurance/Regulatory Affairs Associate who will be coordinating and documenting internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies. The role will also be responsible for the management of the Quality Management System. This includes, but is not limited to, quality manual, operating procedures, training matrix and associated documents.

The opportunity will be a 25-week contract with work hours of up to 35 hours per week. On the rare occasion, this position might require up to 40 hours some weeks but total hours worked for this contract will not exceed 875 hours over the course of 25 weeks. The role allows for remote work in Ontario, Canada. Must be legally eligible for employment and reside in Ontario, Canada.

About Us:

Since 2003, DIVA has introduced and onboarded millions of people as they keenly—or—anxiously—discovered reusable period care. Founded by mother-daughter duo Francine Chambers and Carinne Chambers-Saini, DIVA revolutionized the “feminine hygiene” industry and created the mass market adoption of sustainable period care alternatives. Today, the DIVA brand is synonymous with the menstrual care category, driving change and bringing sustainability to the forefront of new period care innovation.

We are DIVA. Your conscious cycle care partner.

Responsibilities:

ISO/Regulatory/Technical Writing

• Creates, updates, maintains program quality records and work instructions.
• Maintaining and updating all Diva International SOPs on continuous improvement software including revision history and control.
• Creates and/or edits Diva International’s Standard Operating Procedures (SOP) for all departments.
• Update documents to maintain compliance with ISO 13485.
• Support the internal quality system processes.
• Manage training profiles and training matrix for all departments.
• Work in accordance with Diva International Inc.’s Quality Policy and B-Corp set of standards, ISO, GMP and FDA requirements as applicable.
• Ensuring that documentation amongst different functionalities are consistent and be able to suggest necessary changes when required.
• Evaluate documentation effectiveness and develop improvement plans.
• Work with all departments to obtain an in-depth understanding of the documentation requirements.
• Collaborate with Subject Matter Experts on technical content as necessary.
• Support regulatory compliance/agency audit and audit related research, documentation and preparation, in accordance with business goals, regulatory compliance, and legal requirements.

Qualifications:

• Demonstrated ability to research, learn, and explain technical and operating procedures.
• High attention to detail including editing, proofreading, fact-checking to provide high-quality, polished work.
• Preferred experience working in an ISO 13485 environment.
• Demonstrate a high-level commitment to collaboration and team achievement.
• 1-3 years in technical writing, editing, and/or content writing.
• Strong understanding of business practices with fundamental understanding of project management methodology and administrative functions.
• Ability to meet tight deadlines in deliverable-based project
• Ability to write effectively and to be able to translate complex ideas or technical information into easy-to-follow material.
• Quality Assurance or Regulatory Affairs diploma is an asset.
• Understanding of ISO 13485 requirements by certification.
• Bachelor’s degree in science related field.
• Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Strong analytical skills, problem solver, and takes initiatives on projects with limited supervision.

About Our Hiring Process:

Does this sound like great fit for you? We would love to hear from you.

You can expect us to be curious about who you are, what experiences you have gained to date and what you are looking for in your next opportunity. We know that you are selecting us as an employer just as much as we are inviting you to join our team. We will provide a series of opportunities for us to connect and for you to meet various members of our team. Please ask us questions and let us know how we can support you throughout our hiring process.

Why work at Diva International?

People are the heart and soul of DIVA, sharing our passion to make a meaningful difference in the world. We empower our employees to shatter societal norms and status quo, raise our standards, so we can grow together and make a great company even better.

At DIVA, we strive to be a welcoming and safe space for everyone, regardless of their race, national or ethnic origin, colour, religion, age, sex, sexual orientation, gender identity, physical ability, or any other protected grounds. We welcome employees and candidates from these underrepresented groups to help make this vision a reality.

Accommodations are available on request for candidates taking part in all aspects of the selection process. Please e-mail at if you require accommodation. Information related to accommodation requirements will be addressed confidentially.

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