Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistWe are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for enabling technologies in the orthopedic industry. This role will be working on hardware and software as a medical device (SaMD) products for distribution as the Senior RA Specialist. This role will develop and champion regulatory strategies, work within cross-functional teams, liaise with regulatory authorities to support the initial launch of medical devices. This role will also facilitate regulatory strategies which support use of machine learning and artificial intelligence within enabling technology products portfolio.The Senior RA Specialist is responsible for managing regulatory activities within the United States, European Union and Australian markets. This role ensures compliance with Therapeutic Goods Administration (TGA) regulations, EU MDR ISO 13485, ISO 14971, 21 CFR 820 and company-wide quality standards. Working as part of a global RA function, the role will also support in sustainable regulatory activities such as management of postmarket surveillance activities on behalf of legal manufacturers, completing regulatory impact assessments for product changes and providing other regulatory SME support to the business as needed.Key ResponsibilitiesRegulatory AffairsDevelop global regulatory strategies for new product development initiatives, identifying streamlined and least burdensome pathways for marketing authorization of new or modified productsSuggest and lead pre-submission meetings with FDA, Notified Body and TGA as determined to be necessary for select product development pathwaysPartner closely with clinical affairs in development and execution of clinical strategy and necessary clinical investigations and evaluations related to achieving marketing authorizationsAct as regulatory representative on product development teams, providing regulatory input to the PDE/project manager on all facets of regulatory compliance, including but not limited to predicate identification and comparison, verification and validation testing, risk management, standard and common specification conformance, current trends in thinking and decisions by regulatory authoritiesExecute regulatory strategies by preparing submissions and technical documentation for product approvals in the US, EU, and Australia. This includes responding to requests from reviewers and resolving deficiencies in submissions.Partnering with Corporate Market Access team to coordinate and support select international registrations and maintain existing licenses and certifications through renewalsAct as regulatory SME during technical documentation auditsPerform regulatory assessments on product or process changes and execute necessary actions such as appropriate notifications, new 510ks, letters to file, technical file updates, license amendments, etc.Review and approve QMS change orders, design change orders, and NCRs, ensuring changes don't impact safety and effectiveness of products without appropriate regulatory actions being takenReview labeling and marketing collateral to ensure compliance with regulations, approval conditions, and consistency of any claims with appropriate dataOwn and manage specific regulatory-related CAPAs, driving root cause investigation, implementation of actions, and confirming effectivenessSupport completion of HHEs and work the Corporate Shared Services team to manage field actions and recallsMonitor industry-applicable regulations, guidance, standards, and common specifications for new or modified requirements; support initiatives associated with compliance with new or modified requirementsMaintain regulatory metrics for reporting to management, monitoring effectiveness of regulatory processes and ensuring accountability to internal and external stakeholdersParticipates in the review of engineering specifications and quality programs in response to adverse quality levels or return trends.Business CollaborationPartner with Sales, Operations, and other functions to provide practical QA/RA guidance.Review marketing, training, and educational materials to ensure compliance in all geographiesWork with cross-functional teams to ensure projects and initiatives meet regulatory and quality requirements.Align local RA activities with global policies and standards.Qualifications, Skills & ExperienceBachelor's degree in science, biomedical engineering, regulatory affairs, or a related field.5+ years' experience in medical devices, healthcare, or related industry is desirable.Proven skills in preparing regulatory submissions in the US, Europe and TGA (510(k), Technical Documentation and Conformity Assessments).

Experience with international regulatory submissions is a plus.Experience in working on products with machine learning and/or artificial intelligence is a plusExpertise in US, EU and TGA regulations, ISO 13485, ISO 14971, and MTAA Code of Practice.Ability to work independently within a defined business area while collaborating across a large organisation. Communicates changes and progress. Proactively works to manage competing priorities.Analytical – ability to synthesize complex or diverse information and demonstrated ability of attention to detail.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.Technical SkillsAssesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills.Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Strong ability to influence and persuadeWritten Communication - Writes clearly and informatively; Varies writing style to meet needs; Able to read and interpret written information.Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.Initiative – self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectivesBusiness Acumen - Understands business implications of decisions.Emotional Intelligence – Ability to navigate conflict and complex issues requiring interpersonal negotiation, self-regulate emotions and maintain perspective and professionalism during periods of stressDiversity - Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.Judgement - Exhibits sound and accurate judgment; Includes appropriate people in decision-making process.Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.Demonstrates commitment to the Enovis Values, Mission and Vision.Working ConditionsPrimarily office environmentOccasional travel to manufacturing sites, clinical validation sites, and surgeon workshopsHands-on interaction with surgical instruments, navigation hardware, and integrated testing environmentsWho We're Looking For:Passionate About Technology – driven to build integrated systems that improve surgical precision and patient outcomesHighly Collaborative – thrives in multidisciplinary engineering and clinical environmentsDetail-Oriented – focused on system reliability, safety, and performanceProblem Solver – enjoys tackling complex system integration challengesAdaptable – comfortable working in fast-paced, evolving technical environmentsQuality-Focused – committed to building safe and reliable medical systemsCurrently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship."Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.We offer a comprehensive benefits package that includes:Medical InsuranceDental InsuranceVision InsuranceSpending and Savings Accounts401(k) PlanVacation, Sick Leave, and HolidaysIncome Protection PlansDiscounted Insurance RatesLegal ServicesJoin us in creating better together.EQUAL EMPLOYMENT OPPORTUNITY Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees