Regulatory Affairs Specialist, Intermediate

Regulatory Affairs Specialist, Intermediate Join to apply for the Regulatory Affairs Specialist, Intermediate role at Synaptive Medical About Us Synaptive Medical is a Canadian medical device company, based in the Greater Toronto Area (Mississauga, Ontario), providing advanced precision imaging and intervention technology for improved diagnosis and treatment. Synaptive’s suite of products includes MRI systems, surgical planning, navigation, and robotic visualization. These products can be seamlessly combined or used independently in the operating room to improve detection and treatment for oncology, stroke and neurogenerative patients. The company has a global footprint of high‑profile customers operating 24‑7 for the betterment of all patients. Opportunity The Regulatory Affairs Specialist, Intermediate role is a vital role at Synaptive Medical Inc. (SMI) where you will work with various regulatory authorities globally and other departments in the company. You will bring vast medical device regulatory knowledge and in‑depth technical and product development knowledge to this team. You will lead the development of regulatory submissions in multiple jurisdictions and contribute majority of the content while utilizing the Engineering and QA/RA teams as necessary. You will also participate in the regulatory review process with the authorities and ensure that the timing of regulatory filing and licenses are maintained. Your experience in development of regulatory strategy for various medical devices and strategically using this insight to influence the product development pathway will be critical. What You’ll Do Own regulatory filing strategy and submission for SMI’s products and develop content for regulatory filing for products manufactured by Synaptive. Have a good understanding of regulations in the EU, USA, Canada and other jurisdictions, specifically MDR, FDA and Health Canada. Have proven experience working with Notified Bodies, Foreign Agents, Distributors and have a solid understanding of MDSAP, ISO 13485, ISO 14971, ISO 60601 and other relevant standards. Have experience creating Technical Files/Checklist, Clinical Evaluation Reports and Post Market Reports. Represent the regulatory department on product development teams and on project teams ensuring that regulatory requirements are clearly communicated. Oversee and prepare submissions to be filed with the Regulatory Authorities in multiple jurisdictions for surgical, diagnostic imaging and consumable products. Seek out new regulatory requirements and ensure that they are reviewed and that proper risk assessments are performed to maintain compliance. Provide oversight for promotional material, trade shows, marketing collateral of regulated products ensuring compliance with all regulatory requirements. Maintain regular cadence with key stakeholders to ensure ongoing alignment of regulatory strategy and plan. Ensure records are current, maintained and timely renewal of licenses with regulators. Participate in internal/notified body, customer audits both scheduled and unannounced. Manage regulatory recalls, including timely internal response and communication to customers, regulators, notified bodies, agents, distributors and other parties. Empower employees to take responsibility for their jobs and goals; delegate responsibility, expect accountability and provide regular feedback. Communicate appropriately through department meetings, one‑to‑one meetings, email, IM and other interpersonal communication. What You’ll Need Bachelor’s Degree in science or related field. MSc preferred. Certification in a regulatory or quality discipline preferred, such as RAC. Minimum 4 years of experience working in medical devices in an RA leadership role. Knowledge of FDA, MDR, Health Canada Regulations, ISO 13485 and ISO 14971. Experience working directly with the FDA, Health Canada, Notified Bodies on regulatory filings/strategy is required. Similar experience with Health Canada is an asset. Experience with electronic submissions and understanding of regulatory agency processes. It’d Be Amazing If You Had PhD in Regulatory/Science discipline. Some clinical studies/in‑vivo testing in a GLP setting, FDA 21 CFR part 58. Experience using software platforms such as Fusion, Trackwise or MasterControl. Knowledge of 21 CFR 820, ISO13485:2016, MDSAP, MDR and ISO 14971. About You Excellent problem‑solving skills, technical proficiency, and analytical abilities. Excellent communication skills and knowledge in technical writing. Adaptable and drives change in a product development and manufacturing setting. Identify potential problems and take appropriate action. Strong organizational and time‑management skills. Works well in a team setting and is capable of working independently. COVID‑19 Considerations Synaptive takes a leadership role in protecting the health and wellbeing of its employees and the public. The COVID‑19 vaccines are an important public health measure for mitigating the spread of COVID‑19 in the workplace and society. As a condition of employment, the successful candidate will be asked to provide proof of vaccination or a reason protected by legislation why they cannot be vaccinated against COVID‑19. Diversity & Inclusivity Synaptive is based out of one of the most diverse countries in the world. We value differences related to race, ethnicity, national origin, gender, sexual orientation, religion, age, ability and socioeconomic status. We commit ourselves to promoting the recognition and appreciation of our diverse culture and to fostering a respectful environment. Accommodation Synaptive Medical is an equal‑opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People and persons with disabilities. If you request accommodation, Synaptive will consult with you to provide reasonable accommodations according to your specific needs. How to Apply Unless otherwise stated, applications will only be considered from candidates eligible to work in Canada or the country to which they are applying, without sponsorship. If you are interested in this position and can demonstrate that you meet or exceed the requirements, include #GOBRAIN in the top right corner of your resume and complete your online application by clicking “Apply Now” and following the prompts. The successful candidate will be asked to complete background checks. All offers of employment are conditional on satisfactory results of these checks. Seniority level Mid‑Senior level Employment type Full‑time Job function Legal Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Synaptive Medical by 2x Get notified about new Regulatory Affairs Specialist jobs in Mississauga, Ontario, Canada. #J-18808-Ljbffr