Quality Assurance/Regulatory Affairs Specialist (14M Mat Leave Contract)

Diva International Inc. (“DIVA”) is looking for a Quality Assurance/Regulatory Affairs Specialist who will be responsible for the development of regulatory strategy, preparing submissions, and supporting new product development, as well as maintaining regulatory compliance of products and the organization, interfacing with worldwide regulatory bodies, and Brand Protection Initiatives.

The opportunity will be a 14-month contract with work hours of up to 40 hours per week. The role allows for remote work in Ontario, Canada. Travel may be required on occasion. 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:

General Duties:

• Ensure compliance with applicable regulatory standards/requirements;
• Monitor, maintain, update, and arrange the closure of existing complaint files as investigative and corrective action reports are received;
• Point of contact for external consultants in charge of new products
• Prepare, upkeep and manage FDA, Health Canada, and other worldwide regulatory submissions as well as other regulatory related documents;
• Act as the regulatory and quality representative on product developments, communicating regulatory requirements, impact of regulations to the development team, as well as during internal and external meetings;
• Coordinate brand protection initiatives with various departments; Supply Chain, Operations, Sales, and Marketing for both online and retail;
• Other duties as assigned.
• Draft verbal or written feedback to customers and other involved parties regarding investigative actions and results;
• Provide support for currently marketed products; including review of engineering changes, process changes, and labelling changes;
• Resolve potential regulatory issues and questions from regulatory agencies. Negotiate submission issues with agency personnel;
• Establish regulatory strategy and identify deliverables for new products, submissions, and design changes;

Quality:

• Support maintenance of Diva’s ISO 13485 certification and Quality Management System as a whole.
• Report on performance of the QMS to top management
• Establish and maintain Diva’s Quality Standards for Diva products and vendors.
• Promoting awareness of the quality system throughout the organization.
• Work in accordance with Diva International Inc.’s Quality Policy and B-Corp set of standards, ISO, GMP and FDA requirements as applicable.
• Support the internal and external quality system audit process.

Qualifications:

• Proficient in MS Office applications, quality management software & tools, and the ability to learn new software as required;
• 3+ years of medical device or natural health industry experience;
• Experience developing and interpreting standards, guidelines, and special controls;
• Ability to think independently and make sound strategic regulatory decisions;
• Experience in the maintenance of Quality Management Systems, e.g., ISO 13485 and FDA QSR for medical devices;
• Highly organized with the ability to work in a dynamic environment;
• Result-oriented and self-motivated;
• 3+ years of US and international regulatory experience related to consumer goods;
• Multi-lingualism is considered an asset.
• Strong project management skills;
• Ability to evaluate scientific/technical information from a Quality perspective;
• 4-6 years of Canadian regulatory experience related to consumer goods;
• Post-Graduate Regulatory Certification or RAC(CAN) preferred;

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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