Remote
Associate Director, Regulatory Affairs Devices and Combination Products job at A
Remote, Irvine, California, United States, 92620
Associate Director, Regulatory Affairs Devices and Combination Products
Associate Director, Regulatory Affairs Devices and Combination Products Senior Level Manager (Director, Dept Head, VP, General Manager, C-level)
Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly. Health Insurance, Dental Insurance, Vision Insurance, Retirement Savings, Paid Holidays, Paid Illness Leave, Paid Time Off About the RoleAssociate Director, Regulatory Affairs Devices and Combination Products (HybridorRemote) Function:Research & Development Job Type:Full-time Job ID:R00132811 Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok. Job Description The Associate Director, Regulatory Affairs Devices and Combination Products works with internal and external partners to deliver products to patients. Supports regulatory objectives for the company’s development and marketed device/combination products including coordination, management of device global submissions, and CE technical files/design dossiers. Provide support to submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), DE NOVO, post-approval reports, annual reports, export certificates, establishment registrations and device listings. Support the development of the device regulatory strategy and provide device input into the preparation and maintenance of chemistry, manufacturing, and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Support regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support AbbVie at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support, project management and leadership for the (Medical Device Regulation – MDR) implementation globally. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations, and regulatory guidance as well as all AbbVie policies and procedures. This positionfocuses on eye care devices and next generational eye care medicinal delivery products. Responsibilities: Develops and prepares pre-market regulatory submissions. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required, device regulatory product strategies,and identifies data and information requirements.Seeks expert advice and technical support as required for strategies and submissions. Makes decisions and provides guidance for support of medical device and combination products. Manages the preparation and management of regulatory applications for devices and combination products, including new investigational applications and amendments, device technical files for pre-market notification and approval, and post-approval change applications.Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies. Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions.Serves as the point of contact for the regulatory agency meetings. Regularly informs regulatory management of important timely issues. Trains, develops, and mentors individuals; may include formal supervisory responsibilities. Develops and implements policies and procedures within the regulatory affairs department. Analyzes legislation, regulation, and guidance and provides analysis to the organization. Represents RA Device on product development teams and design control teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects. This opportunity can be based in AbbVie's Irvine, CAofficeorremotely within the US. Qualifications Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject Preferred Education: Relevant advanced degree preferred. Certification a plus Required Experience: 12+ years pharmaceutical or industry related experience. 5+ years in quality systems and process improvement or regulatory affairs. Proven 7+ years in a leadership role with strong management skills. Experience working in a complex and matrix environment. Strong communication skills, both oral and written. Preferred Experience: 5 years in regulatory affairs. 10 years pharmaceutical experience (medical device/combination product). 5 years in Discovery, R&D, or Manufacturing. Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority. Note: Higher education may compensate for years of experience. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html https://www.abbvie.com/join-us/reasonable-accommodations.html
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Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly. Health Insurance, Dental Insurance, Vision Insurance, Retirement Savings, Paid Holidays, Paid Illness Leave, Paid Time Off About the RoleAssociate Director, Regulatory Affairs Devices and Combination Products (HybridorRemote) Function:Research & Development Job Type:Full-time Job ID:R00132811 Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok. Job Description The Associate Director, Regulatory Affairs Devices and Combination Products works with internal and external partners to deliver products to patients. Supports regulatory objectives for the company’s development and marketed device/combination products including coordination, management of device global submissions, and CE technical files/design dossiers. Provide support to submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), DE NOVO, post-approval reports, annual reports, export certificates, establishment registrations and device listings. Support the development of the device regulatory strategy and provide device input into the preparation and maintenance of chemistry, manufacturing, and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Support regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support AbbVie at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support, project management and leadership for the (Medical Device Regulation – MDR) implementation globally. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations, and regulatory guidance as well as all AbbVie policies and procedures. This positionfocuses on eye care devices and next generational eye care medicinal delivery products. Responsibilities: Develops and prepares pre-market regulatory submissions. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required, device regulatory product strategies,and identifies data and information requirements.Seeks expert advice and technical support as required for strategies and submissions. Makes decisions and provides guidance for support of medical device and combination products. Manages the preparation and management of regulatory applications for devices and combination products, including new investigational applications and amendments, device technical files for pre-market notification and approval, and post-approval change applications.Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies. Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions.Serves as the point of contact for the regulatory agency meetings. Regularly informs regulatory management of important timely issues. Trains, develops, and mentors individuals; may include formal supervisory responsibilities. Develops and implements policies and procedures within the regulatory affairs department. Analyzes legislation, regulation, and guidance and provides analysis to the organization. Represents RA Device on product development teams and design control teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects. This opportunity can be based in AbbVie's Irvine, CAofficeorremotely within the US. Qualifications Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject Preferred Education: Relevant advanced degree preferred. Certification a plus Required Experience: 12+ years pharmaceutical or industry related experience. 5+ years in quality systems and process improvement or regulatory affairs. Proven 7+ years in a leadership role with strong management skills. Experience working in a complex and matrix environment. Strong communication skills, both oral and written. Preferred Experience: 5 years in regulatory affairs. 10 years pharmaceutical experience (medical device/combination product). 5 years in Discovery, R&D, or Manufacturing. Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority. Note: Higher education may compensate for years of experience. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html https://www.abbvie.com/join-us/reasonable-accommodations.html
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