Associate Director Global Regulatory Affairs- Soft Tissue Fillers
Associate Director Global Regulatory Affairs- Soft Tissue Fillers
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Job Description
The Associate Director of Regulatory Affairs Soft Tissue Fillers supports regulatory objectives for the companys soft tissue fillers devices for new products introduction (NPI) including coordination management of global submissions to support new registrations. As Global regulatory lead (GRL) directs and supports development of the regulatory strategy related to NPI activities for device regulatory activities in a variety of countries including but not limited to US EU Japan and China.
Supports regulatory intelligence and policy activities in monitoring regulatory pathways legislation updates policies and initiatives that could impact new products introduction. Supports Aesthetics business at Regulatory Authority/Notified Body meetings as well as industry meetings. 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 company policies and procedures.
Responsibilities:
- Leads team and provides regulatory guidance to ensure compliance with applicable medical device regulations for new products.
- (If applicable) Manages direct reports; maintains high levels of work and employee accountability further develop the team to ensure a quality mindset.
- Provides leadership and expertise for: regulatory strategy regulatory operations interactions with regulatory agencies/Notified Bodies technical file/design dossier management and approval of Regulatory documents/statements.
- Supports regulatory interactions with R&D Quality Medical Safety and International Regulatory Affairs colleagues.
- Provides regulatory policy intelligence interpretation and strategy for medical devices to support global regulatory plans due diligence integration and divestitures.
- Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues.
- Supports and develops global regulatory teams to meet company objectives.
This position is located onsite in Irvine CA.
Qualifications :
- Bachelors degree or equivalent. Relevant advanced degree in a scientific discipline is highly desirable.
- At least 10 years of regulatory experience in the medical device industry with global US and international experience.
- Strong knowledge of medical device regulations global regulatory strategy and regulatory submission process.
- Proven experience and ability to manage relationships with regulatory agency personnel.
- Drive proactive initiatives to ensure compliance.
- Ability to travel up to 10 of time
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 :
Fulltime
Employment Type
Full-time
