Regulatory Affairs Manager
RESPONSIBILITIES – MISSION
The mission of the Regulatory Affairs Specialist Manager is to work with our VP Regulatory & Quality Assurance to design and execute ARC’s regulatory strategy to maximize market access for ARC’s medical devices for the reduction of post-surgical adhesions.
• Are an entrepreneur in a Regulatory Specialist’s body
• Have a fearless personality and a yearning to change the world
• Love to draft regulatory documents
• Enjoy conducting regulatory intelligence
• Are passionate about preventing surgical adhesions
• Desire to have a substantial, direct impact on the success of the products you develop and the company you work with
• Perform remarkably or fail big, rather than perform adequately
• Figure out how to fix it (instead of who’s to blame)
• Within the first 90 days, work with our VP Regulatory & QA and VP Clinical Trials in determining the optimal global regulatory strategy and designs for clinical, post-market and registration trials, including clinical and economic outcomes, based on the requirements of patients, surgeons, hospitals, regulators, payers, companies interested in acquiring ARC or distributing ARC’s products, and any other relevant stakeholders (including reviewing device classification and global regulatory strategy; and including performing a gap analysis of our current development activities using recognized international standards)
• Within the first 60 days, work with our VP Regulatory & QA and VP Clinical Trials to initiate the regulatory process for clinical trials in the EU, China and other territories for our first-in-human clinical trial and at least three additional trials (including preparing technical documentation for clinical trial applications)
• Within the first 60 days, work with our VP Regulatory & QA and Engineering & Scientist Team in completing the implementation of and obtaining ISO 13485 Certification for our quality management system (including generating procedures related to regulatory affairs)
• Ensure compliance with all applicable regulatory standards related to global clinical trials.
WHO OR WHAT IS ARC MEDICAL DEVICES?
ARC is developing and commercializing novel, first-in-class solutions to prevent post-surgical adhesions – which if not prevented cause pain & suffering, organ dysfunction, infertility, and death; and for which there is a dire unmet medical need.
Our products are non-viscous, liquid, polysaccharide-based medical devices. Our preclinical data in numerous surgical adhesion models show that our product flows throughout the entire surgical site and reduces the formation of surgical adhesions throughout the entire surgical site. We’ve recently built a manufacturing facility & QC laboratory; and are implementing our quality management system now. We will initiate first-in-human and follow-on clinical trials in the near-term.
• Work to positively transform the health of millions of surgery patients
• Care more about your ability to lead and pioneer than your experience
• Are building a start-up: we work long, hard hours with some flexibility and we take time to celebrate our achievements
• Are implementing efficient systems in the midst of scale-up chaos
• Are not afraid to make mistakes
WHY WORK AT ARC MEDICAL DEVICES INC.?
• Mission: We are doing something super-important that no one else is going to get done: using our novel, liquid medical device we are reducing the formation of surgical adhesions throughout the entire surgical site.
• People: We have a superstar team that is passionate about improving their own & others’ health and is fun to work with (also a bit goofy). Every member of our team is prioritized, driven, trustworthy, self-improving, smart, creative, and efficient. Our team is built of diverse international people across various disciplines – all of whom enjoy the outdoors, be it hiking, trail-running, camping, kayaking, kiteboarding, snowboarding, downhill skiing, cross-country skiing or other outdoor activities.
• Family: As part of our hiring and post-hiring processes – we ensure that ARC is the correct fit for our team members’ families.
• Fun: 1) We hire the right people for the right job so that our folks do what they love doing while helping get our products to patients. 2) Our entire team has lunch together on Fridays; occasionally we have Friday Beer O’Clock; and we also have a ‘celebration day’ after achieving an aggressive milestone – including activities like go-kart racing, mini-golf, and beer brewing.
REQUIRED DESIGNATIONS AND EXPERIENCE
• BSc or higher in applicable degree e.g. Engineering, Bio-Medical Engineering, Computer Science, Biology, or Chemistry or related field
• 5-10+ years combined hands-on experience running regulatory programs for medical devices and/or pharmaceuticals
• Regulatory registration in international markets such as Europe, China, Japan, and the United States of America
• Regulatory working knowledge of requirements such as 21 CFR 820, 21 CFR 201, ISO 13485 and EU MDR
• Regulatory experience with trial applications, marketing approvals, adverse event reports, labeling and quality systems
• Preferably regulatory experience is in surgical settings for medical devices and/or pharmaceuticals
• Fluent in English
• Working knowledge of regulatory terminology in German, Chinese, &/or Japanese is an asset
COMPETENCIES – ROLE SPECIFIC
• Detail/Attention to Detail
• Standards/High Standards
• Open Minded and Skilled Listener
• Strategic Visioning / Thinking
COMPETENCIES – CULTURE FIT
• Prioritized / Drives Decisions & Their Execution / Goal-oriented Organization, Planning & Execution / Action Management
• Teamwork / Collaboration / ‘Chemistry’ / Interpersonal Skills
• Driven & Fast-Paced Work Ethic / Commitment / Determination / Perseverance / Resilience / Energy Level and Aggressive & Assertive
• Honest, Integrity and Trustworthy
• Self-Improvement / Seeks Feedback and Criticism / Coachable
• Ego Under Control / Humble / Kind
• Passionate about Personal and Others’ Health
• Smart / Intelligent / Clever / Learner / Perceptive
• Creative / Innovative / Inventive
EQUAL OPPORTUNITY EMPLOYER
We are an equal opportunity employer and evaluate applicants without regard to race, colour, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
We anticipate that approximately 10% of the time for this position may include international travel.
We are in Richmond, British Columbia, Canada – right beside Vancouver. From our facilities to the Vancouver International Airport is about a 10-minute drive; and to the heart of downtown Vancouver is about a 30-minute drive.
HOW TO APPLY
• Tell us in eight sentences or less why you’re interested in ARC and how your past accomplishments show what unique contributions you can make to our Team, including how you will rapidly initiate and complete the work to meet the Outcomes outlined above.
• Email your cover letter and CV in pdf and include the name of this position in the subject heading to email@example.com
• Due to the anticipated volume of responses, we will contact only those candidates who most closely match our requirements.
Commensurate with Experience $60,000 – 90,000
Application Deadline: November 16, 2018