Diva International Inc. Looking for Manager – Quality Assurance & Regulatory Affairs at Remote Full Time

Diva International is a modern menstrual company built on quality, education, advocacy, and inclusivity, we’re on a mission to provide life-changing sustainable wellness solutions for every stage of a woman’s journey. A B-Corp committed to ethics & sustainability means our values and business practices places people and the planet equal to achieving profit. We deliver premium products with proven results that are safe for people and the planet!

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The Role*
Reporting to the VP of Product & Operations, you 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.
You will also act as the Quality Management System Representative for Diva by ensuring compliance with the ISO 13485:2016 Standard under the Medical Device Single Audit Program (MDSAP).

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About You*
Experienced in all matters regulatory and quality related, you are defined by your integrity, reliability and trustworthiness. You communicate well with others and are a team player who wants to foster collaboration despite competing priorities. You are able to think independently and make sound strategic decisions. Having participated in both internal and external audits, your preparedness, research, and creativity to ensure successful outcomes.

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Task & Responsibilities*
General Duties:

• Prepare, upkeep and manage FDA, Health Canada, and other worldwide regulatory submissions as well as other regulatory related documents;

• Resolve potential regulatory issues and questions from regulatory agencies. Negotiate submission issues with agency personnel;

• Ensure compliance with applicable regulatory standards/requirements;

• Point of contact for external consultants in charge of new products

• Establish regulatory strategy and identify deliverables for new products, submissions, and design changes;

• 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;

• Provide support for currently marketed products; including review of engineering changes, process changes, and labelling changes;

• Monitor, maintain, update, and arrange the closure of existing complaint files as investigative and corrective action reports are received;

• Draft verbal or written feedback to customers and other involved parties regarding investigative actions and results;

• Coordinate brand protection initiatives with various departments; Supply Chain, Operations, Sales, and Marketing for both online and retail;

• Other duties as assigned.

Quality:

• Maintain Diva’s ISO 13485 certification and Quality Management System as a whole.

• Provide direction to ISO/Regulatory Assistant in maintaining ISO 13485 QMS

• Report on performance of the QMS to top management

• Support the internal quality system audit process.

• Promoting awareness of the quality system throughout the organization.

• Work in accordance with Diva International’s Quality policy.

• Establish and maintain Diva’s Quality Standards for Diva products and vendors.

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The ideal candidate possesses the following:*

• 4-6 years of Canadian regulatory experience related to consumer goods;

• 3+ years of US and international regulatory experience related to consumer goods;

• 3+ years of medical device or natural health industry experience;

• Experience in the maintenance of Quality Management Systems, e.g., ISO 13485 and FDA QSR for medical devices;

• Post-Graduate Regulatory Certification or RAC(CAN) preferred;

• Experience developing and interpreting standards, guidelines, and special controls;

• Ability to evaluate scientific/technical information from a Quality perspective;

• Ability to think independently and make sound strategic regulatory decisions;

• Proficient in MS Office applications, quality management software & tools, and the ability to learn new software as required;

• Highly organized with the ability to work in a dynamic environment;

• Strong project management skills;

• Result-oriented and self-motivated;

• Multi-lingualism is considered an asset.

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This role can be 100% remote in Canada with a head office location in Kitchener, Ontario. Please note that occasional travel may be required to our head office location or to our vendor locations (a few times a year). Must be legally eligible for employment and reside in Canada._*

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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 challenge the status quo so we can grow together and make a great company even better.
We offer a competitive compensation plan, employer matched RRSPs, comprehensive health and dental coverage, a flexible remote work environment and an educational assistance program to help you keep learning.
Diva strives 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, disability, or any other protected grounds.
We are committed to integration and equal opportunity. Accommodation is available to all applicants upon request throughout our recruitment process. Please contact Human Resources at 1-866-444-3482 ext. 253 or email at [email protected] if you require accommodation. We will work with all applicants to accommodate their accessibility needs.

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Job Type: Full-time