Regulatory Affairs Manager

AceAge is a healthcare technology company, creating intuitive products to improve health outcomes and empower patients to live healthier and better lives. In close collaboration with healthcare personnel and our users, we have developed Karie - a personal health companion that organizes, schedules and dispenses medication with one-button technology. With help from the medication dispenser, patients are taking the right medication at the right time. Increased feeling of safety, control, and independence are all patient benefits that come with using Karie.

As a healthcare technology start-up, we thrive on innovation and technological advancement. Earlier this year we joined forces with Dignio, a Norwegian health tech company specializing in remote care, including medication compliance and remote patient monitoring. Today, Karie is being used by patients in several countries around the world. By offering cutting-edge and user-friendly technology, we strive to make the healthcare system more sustainable going forward. Together, we bring healthcare home.

**The Package**

Our Compensation package includes a competitive base salary and benefits that include LTD, Life Insurance, AD&D Coverage, Extended Healthcare and Vision Coverage. We also offer paid Sick Days, Family Responsibility Days, and Bereavement Leave. We will also provide you with the ability to engage and participate in a variety of corporate initiatives. We are a company that is focused on individual development and success in addition to your wellness. We also have an absolutely amazing team

**Regulatory Affairs Manager (Hybrid)**

The Regulatory Affairs Manager is responsible for the preparation and on time regulatory-filing and preparing responses to questions from regulatory agencies. In addition, the role is responsible for reviewing the portfolio of products to ensure proper management from a regulatory perspective. The role will work closely with the Product team on new product development, necessary regulatory activities required for product market entry, and in-market device management. This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.

**Job responsibilities and duties**
- Ensure all products including hardware, electronics, software, platform, apps, and IT hardware comply with the US, Canada and EU Regulations, Laws, Acts, and associated policies
- Update, finalize and implement a QMS. Ensure all policies and procedures comply with regulations.
- Work closely with product development stakeholders by preparing regulatory assessments and plans for regulatory requirements in the US, Canada and EU (FDA, MDEL, MDR)
- Author documentation and regulatory filings and prepare responses to questions from the regulatory agencies
- Work closely with Support and Quality teams on complaints, recalls and mandatory reporting
- Review labeling, marketing literature, and user manuals to ensure regulatory compliance
- Coordinate and review external labs that perform regulatory testing
- Work with IT to ensure all internal hardware and software systems comply with information security regulations (GDPR, HIPAA, PHIPA)
- Work with OEM to ensure proper documentation is maintained to satisfy product design regulatory requirements (ISO)

**What you will need to be successful in the role**
- Bachelor’s degree in Engineering, Science or related discipline
- Post-graduate diploma/certification in Regulatory Affairs is an asset
- 3-5 years of experience working on international regulations for Consumer Products and Medical Devices (Canada, US, and Europe) is required
- 3-5 years of working regulatory experience in an electrical/electronic and/or software medical device environment is required
- Experience interfacing with Regulatory Agencies
- Knowledge and experience implementing and working with international standards applicable for Medical Devices and its components (ISO 13485, ISO 14971, IEC 62304, IEC 60601 etc.) is an asset
- Knowledge in Project Management and Quality Assurance is an asset
- Strong written and oral communication skills, with the ability to present complex ideas in a simple manner
- Self-motivated and able to work with mínimal supervision
- Strong attention to detail with the ability to multitask and meet deadlines in a timely manner
- Excellent analytical, organizational, and problem-solving skills
- Proven ability to adhere to standards/procedures and maintain confidentiality
- Able to effectively work with other teams to achieve objectives

**Working Conditions**
- This position will be a hybrid role with a requirement to be on site a minimum of 2 pre-selected days a week.

**Additional Information**

Although we thank everyone for their interest in the role, and their time in applying, we will look to respond to those who are successf