The Associate Director of Regulatory Affairs – Body Contouring supports regulatory objectives for the company’s body contouring devices including coordination, management of global submissions. Directs and supports development of the regulatory strategy and submission activities for device regulatory approvals in a variety of counties including EU, US, Japan, and China. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support ZELTIQ/Allergan Aesthetics 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.
- Leads and/or supports medical device development (including software controlled medical devices) and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the device/combination product.
- Supports regulatory submissions, regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues.
- Provides regulatory policy, intelligence interpretation and strategy (e.g., Medical Device Regulation) for medical devices to support global regulatory plans, due diligence, integrations 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.
- Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability.
- Supports and develops global regulatory teams to meet company objectives.
- Bachelor’s Degree (pharmacy, biology, pharmacology) or related life sciences. Relevant advanced degree in a scientific discipline is highly desirable.
- 8 years of regulatory experience in the medical device industry.
- Master’s degree, with a minimum of 6 years of Regulatory experience with software-controlled medical devices preferred.
- Experience in the CE Marking process, global regulatory strategy, and regulatory submission process.
- Proven experience in and ability to manage relationships with regulatory agency personnel.
- Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance.
- Strong knowledge of medical device regulations
- Ability to travel up to 10 % of time
Significant Work Activities: N/A
Travel: Yes, 15 % of the Time
Job Type: Experienced