Regulatory Affairs Specialist at Actalent — NeverHard

Job DescriptionJob Description Job Title: Regulatory Affairs Specialist Job Description Discover meaningful purpose through your life's work by joining a team dedicated to transforming lives with innovative medical solutions. This role supports regulatory submissions and compliance activities for a Class III medical device used in liver cancer treatment. Responsibilities Prepare, submit, and manage regulatory submissions through to approval, ensuring product registrations are reviewed and renewed as required. Support internal and external regulatory audits. Communicate with regulatory agency personnel to expedite submission approvals and address related inquiries. Serve as a core team member for product development teams, providing Regulatory Affairs guidance throughout the development lifecycle. Conduct regulatory assessments for product and manufacturing changes to ensure compliance with applicable regulations. Build and maintain strong working relationships with cross-functional partners, including regional Regulatory Affairs colleagues, to secure timely support for regulatory deliverables. Demonstrate a commitment to patient safety and product quality by adhering to the Quality Policy and all documented quality processes and procedures. Essential Skills Bachelor's degree in a Scientific, Engineering, or Technical discipline. Experience with FDA, EU, and/or international medical device regulations. Hands-on submission experience, including Design Dossier and Technical File reviews, PMA/510(k) submissions, and/or international submissions. Regulatory Affairs certification (e.g., RAC). Regulatory experience with Class III medical devices. Understanding of the product development process and design control practices. Proficiency in Microsoft Office and Adobe Acrobat, with the ability to work effectively with databases, document control systems, and quality management software. Work Environment Work in a dynamic environment dedicated to improving health with innovative medical technology. Utilize state-of-the-art software tools such as Microsoft Office and Adobe Acrobat. Collaborate with cross-functional teams in a professional setting focused on quality and patient safety. Job Type & Location This is a Contract position based out of Ottawa, ON. Pay and Benefits The pay range for this position is $40.86 - $45.67/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Workplace Type This is a hybrid position in Ottawa,ON. À propos d'Actalent Actalent est un leader mondial dans les services d’ingénierie et de sciences ainsi que dans les solutions de talents. Nous aidons des entreprises visionnaires à faire progresser leurs initiatives d’ingénierie et de science grâce à l’accès à des experts spécialisés qui favorisent l’échelle, l’innovation et la rapidité de mise sur le marché. Avec un réseau de près de 20 000 consultants et 5 000 clients à travers les États-Unis, le Canada, l’Asie et l’Europe, Actalent dessert de nombreuses entreprises du Fortune 500. Nous sommes fiers d’être l’une des 500 meilleures firmes de conception de l’Engineering News-Record (ENR) pour nos services de conception en ingénierie et un lauréat du prix ClearlyRated Best of Staffing® tant pour le service client que pour les talents. Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi. Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à actalentaccommodation@actalentservices.com pour connaître d’autres options d’accommodement. Ordonnance sur l’égalité des chances de San Francisco: Conformément à l’Ordonnance sur l’égalité des chances de San Francisco, pour tous les postes situés dans la ville et le comté de San Francisco, nous examinerons les candidatures des personnes qualifiées ayant un casier judiciaire ou des antécédents criminels. Utilisation de l’intelligence artificielle (IA): Nous pouvons utiliser l’intelligence artificielle (IA) pour soutenir certaines étapes de notre processus d’embauche, notamment la recherche, la présélection et l’évaluation des candidatures. L’IA aide à analyser les candidatures et les qualifications, mais les décisions finales sont prises par notre équipe de recrutement. En soumettant votre candidature, vous reconnaissez et acceptez que celle-ci puisse être examinée à l’aide d’outils d’IA. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.