The 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

• You will own regulatory filing strategy and submission for SMI’s products AND the develop content for regulatory filing for products that are manufactured by Synaptive.
• Must have a good understanding of regulations in the EU, USA, Canada and other jurisdictions, specifically MDR, FDA and Health Canada
• Proven experience having worked with Notified Bodies, Foreign Agents, Distributors and having a solid understanding of MDSAP, ISO 13485, ISO 14971, ISO 60601 and other relevant standards.
• Must have experience creating Technical Files/Checklist, Clinical Evaluation Reports and Post Market Reports
• Represents the regulatory department on product development teams and on project teams ensuring that regulatory requirements are clearly communicated
• Oversees and prepares 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 ensure ongoing compliance to existing and new regulations
• Provides oversight for promotional material/trade shows, marketing collateral, of regulated products ensuring that compliance with all regulatory requirements are met.
• Regular cadence with key stakeholders to ensure ongoing alignment of regulatory strategy/plan with stakeholders
• Ensure records are current and maintained, including timely renewal of licenses with regulators
• Participate in internal/notified body, customer audits both scheduled and unannounced
• Key participant in the management of regulatory recalls, including timely internal response and timely communication to customers, regulators, notified bodies, agents, distributors and other parties
• Empower employees to take responsibility for their jobs and goals. Delegate responsibility and expect accountability and regular feedback.
• Appropriately communicate through department meetings, one-on-one meeting and appropriate email, IM, regular 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’ 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/the electronic submission process and how regulatory agencies operate

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 platform, 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
• Able to adapt and drive change in a product development and manufacturing setting
• Ability to identify potential problems and take appropriate action
• Strong organizational and time management skills
• Must be able to work with others in different disciplines
• Must be able to work in a team setting and on individual basis