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1 week ago
Sonova AG Valencia, United StatesOverview · Primary role is to participate in product development activities with R&D from conception of new product to submission and deployment of new product. Participate in activities to ensure compliance with worldwide regulatory requirements. · What you'll do: Establish pr ...
Principal Specialist, Regulatory Affairs - Santa Clarita, United States - Sonova AG
Description
OverviewPrimary role is to participate in product development activities with R&D from conception of new product to submission and deployment of new product.
What you'll do:
Establish procedures to comply with cybersecurity regulatory requirements.
Work with the RA team to help develop and implement process improvements throughout the regulatory processes.
Participates in development teams and provides input to assure that worldwide regulatory requirements and standards are incorporated in the product development process and design/ manufacture of the product`s to ensure compliance with regulatory requirements for Class III Medical Devices.
Collaborate with RA Country Managers to identify country specific requirements relevant to product development projects such as special testing and labeling requirements.
Generate master submission documents to support worldwide submission activities including licence renewals & annual reports.Participate in the engineering change order process, by reviewing engineering and manufacturing document release and changes.
Manage/Supports testing, training and implementation activities for quality system projects.
Keep abreast of new or developments in various regulations and advise Regulatory Affairs management as necessary.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Responsible for ensuring compliance to all relevant quality system regulations, including EU MDR Regulation, ISO 13485:2016, 21 CFR Part 820, and all regulations applicable for MDSAP certificationDevelop, implement and manage procedures for regulatory compliance on cybersecurity.
Provide guidance to Product Development Teams for Regulatory Compliance World Wide.Prepare submissions and manage any additional information Requests from the agencies.
Provides guidance and training to other Regulatory Affairs team members in lower level positions.
Other duties as assigned.
Travelling Requirement:
up to 10%What you bring to the team:EducationBachelor's degree in a scientific discipline or engineering or additional equivalent work experienceNice to HaveMasters or PhD in a Scientific DisciplineWork ExperienceAt least 10 years of experience in worldwide regulatory affairs (both submissions and compliance) at medical device companies.
Nice to HaveExperience in the Class III medical device environmentPersonal CompetenciesCritical Thinker, Highly organized, efficient and self-motivatedStrong attention to detail, accuracy and ability to handle multiple tasksAbility to work under pressure and with cross-functional teamsNice to HaveProject management skillsHigh learning aptitude and adaptability with systems and regulatory landscapeSocial CompetenciesSelf-Motivated Team player who seeks to help and learn from colleaguesExcellent interpersonal, communication, and negotiating skillsLeadership CompetenciesAbility to communicate persuasively in a manner that supports approvals and other key company goals/objectivesProfessional CompetenciesGood working knowledge of Global requirement including EU MDR regulations and standards.
Excellent writing, proof reading and data management skillsGood working knowledge of class III medical device labeling requirementsExcellent time management and problem solving skillsNice to HaveRA certification by Regulatory Affairs Professional SocietyLanguage(s)/ LevelEnglish/ ProficientIT SkillsProficient with Microsoft Office suiteWorking knowledge of cloud based systemsSAP and Salesforce experienceOur offer:Exciting and challenging work environmentComprehensive benefits packageTraining and development opportunities - we believe every employee deserves a development plan.
Come, learn, and grow with usDon't meet all the criteria? If you're willing to go all in and learn we'd love to hear from youWe love to work with great people and strongly believe that a diverse team makes us better.
We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.
We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Senior Manager, Human Resources.Pay Ranges:
$91,200/yr - $136,800/yrBased on locationHealth Benefits & Perks:Medical, dental and vision coverage*Health Savings, Health Reimbursement, Flexible Spending/Dependent Care AccountsTeleHealth options401k plan with company match*Company paid life/ad&d insurance Additional supplemental life/ad&d coverage availableShort/Long-Term Disability coverage (STD/LTD) STD LTD Buy-ups availableAccident/Hospital Indemnity coverageLegal/ID Theft AssistancePTO & paid holidays*Employee Assistance Program*Plan rules/offerings dependent upon group Company/location.
Sonova is an equal opportunity employerWe team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place.
We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
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