Regulatory Affairs Specialist

Patterson isn't just a place to work, it's a partner that cares about your success.One of the distinguishing marks of our company is the talented people who embrace the people-first, always advancing, and results-driven culture. Professional growth abounds in this motivating environment. We value the diverse talents and experiences our employees bring to Patterson and believe that they build a stronger and successful organization.The Regulatory Affairs Specialist is responsible for ensuring comprehensive compliance with regulatory requirements throughout the entire product lifecycle - from initial development and manufacturing to distribution and post-market surveillance. This role ensures that products meet established standards for safety, efficacy, and quality.Key responsibilities include obtaining and maintaining regulatory approvals, supporting cross-functional teams, and ensuring alignment with applicable laws, regulations, and industry standards. These include, but are not limited to, the U.S. Food and Drug Administration (FDA), Canadian Medical Device Regulations (CMDR), and European Union Medical Device Regulation (EU MDR).Essential FunctionsAuthors global Regulatory Strategies by applying acquired skills and knowledge to processes and procedures and interpreting country specific regulationsAuthor global submissions for Class I-IV medical devices, and prescription drugs globally, which includes (but not limited to) US, European Union, and CanadaComplete required data entry into systems such as Health Canada, FDA FURLS, GUDID, and EUDAMEDInterpret and apply regulatory and quality requirements using a risk-based approach to enable effective decision-making and proposing solutionsSupport internal and external audits; help facilitate federal drug and medical device inspectionsStay current on industry trends in relation to compliance regulations for drugs and medical devicesCreate and update Quality Management System (QMS) procedures and processes that fall under Regulatory responsibilityInform stakeholders of Corrective and Preventive Action (CAPA) and Supplier controlsProvide support to the QMS team through ongoing cross-training initiativesComply with Company and department policies and standards; performs other duties as assignedMinimum RequirementsBachelor's Degree in Business, Law, Regulatory Affairs or related field or equivalent education and/or experience2 years experience in regulatory affairs within the medical device and drug related regulatory fieldexperience with QMS and regulatory systemsPreferred RequirementsExperience with Health Canada regulated environmentSkills and AbilitiesKnowledgeable in QMS (Quality Management System) regulations (not limited to) 21 CFR Part 820, ISO 13485, CMDR, GUI-0001 and others as applicableUnderstanding of global medical device regulations (e.g., FDA QSR, EU MDR, Canada MDR, MDSAP and ISO standards)Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meet deadlines in timely mannerStrong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization; strong customer service-oriented skillsStrong organizational, analytical, and creative problem-solving skills and track record contributing to teamwork practices with a moderate impact on functional objectivesHighly self-motivated and directed; able to carry out responsibilities with latitude and limited supervisionPhysical and Cognitive DemandsCommunicate/Hearing FrequentlyCommunicate/Talking FrequentlyLearn New Tasks or Concepts FrequentlyMake Timely Decisions in the Context of a Workflow FrequentlyComplete Tasks Independently ConstantlyMaintain Focus ConstantlyRemember Processes & Procedures ConstantlyStationary Position (Seated) ConstantlyVision ConstantlyWhat's In It For You: (https://www.pattersoncompanies.com/join-us/)We provide competitive benefits, unique incentive programs and rewards for our eligible employees:Full Medical, Dental, and Vision benefits and an integrated Wellness Program401(k) Match Retirement Savings PlanPaid Time Off (PTO)Holiday Pay & Floating HolidaysVolunteer Time Off (VTO)Educational Assistance ProgramFull Paid Parental and Adoption LeaveLifeWorks (Employee Assistance Program)Patterson Perks ProgramThe potential compensation range for this role is below. The final offer amount could exceed this range, based on various factors such as candidate location (geographical labor market), experience, and skills.$77,200.00 - $100,333.33EEO StatementPatterson provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or other related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.At Patterson Companies, we live our values everyday. With more than 8,000 employees worldwide, we're responsible for providing dentists, veterinarians, animal producers, and farmers with the support they need to keep us and our animals healthy.An Equal Opportunity EmployerPatterson Companies, Inc., is an equal opportunity employer. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability or veteran status, among other factors.