Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote)
Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote)
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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 companys 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 position focuses 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.
- Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves change management requests.
- 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 AbbVies Irvine CA office or remotely within the US.
Qualifications :
- Required Education: Bachelors 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 or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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 visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
