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 Senior Manager, Regulatory Affairs (Ref:siemens-363844) |
| Company: |
Siemens
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| Location: |
Knoxville, TN |
| Pay Range: |
N/A |
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| Job Type: |
Information Technology
Other
Transportation
Healthcare
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| Relocation Expense: |
None |
| Required Experience: |
Not Specified |
Required Education: |
Not Specified |
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Need Assistance?
Call (828) 681-8975
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Senior Manager, Regulatory Affairs
Company Siemens Medical Solutions USA, Inc.
Division SMS - Molecular Imaging
Functional Area QA - Quality Assurance/Regulatory Affairs/Regulatory Compliance
Location TN - Knoxville
Req ID 108021 Job Type Regular
Job Time Full-Time
Experience Level Senior Level
Required Education Bachelors Degree or equivalent experience
Required Travel 30%
Company Description
We are one of the largest global suppliers of healthcare equipment, renowned for innovative products, services and solutions including diagnostic imaging systems, therapy equipment for treatment and electromedicine and IT solutions to optimize workflow and increase efficiency in the healthcare industry.
Siemens is an Equal Opportunity Employer encouraging diversity in the workplace.
Job Description
We are currently looking for a Senior Manager of Regulatory Affairs in Knoxville, TN. This position will be responsible for development of global regulatory strategies and planning and preparation of regulatory submissions for development and commercial products (IND/NDA/MAA). This individual will support regulatory interactions with FDA or other health authorities as needed throughout the product life cycle. This person will be primary regulatory support for product development group to set up FDA meetings, teleconferences and advisory committee meetings, production of associated records of regulatory authority meetings and assistance in preparing briefing documents.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
§ Responsible for developing a global product regulatory strategy for assigned projects & products
§ Develop a product regulatory timeline aligned to Siemens MI strategic goals for clinical and commercialization strategy with key regulatory milestones and activities for agency filing
§ Liaise with regional & country-specific pharmaceutical regulatory affairs personnel for international submissions and registrations
§Participate as a member of the product team to make certain compliance with product specifictions and regulatory requirements
§ Review and approve product submission documents to ensure compliance for assigned products
§ Manage regulatory personnel and interactions with other functions (e.g., Quality, Operations, EHS) during regulatory agency inspections
§ Provide regulatory guidance/input to internal product review boards
TECHNICAL COMPETENCIES:
§ Knowledge of pharmaceutical industry regulatory compliance
§ Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical products
§ Knowledge of clinical development, including responsibilities for successful adherence to development milestones, marketing authorization, meeting facilitation, labeling negotiations, regulatory responses
§ Understands regulatory issues related to product patent protection and exclusivity
§ Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product regulatory activities
§ Ability to influence and partner with cross-functional teams in a global pharmaceutical organization
§ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
§ Ability to assess project risks, and where appropriate, recommend contingency plans, and strategies to mitigate regulatory risks
*10 plus years of experience drug development and regulatory strategy experience.
* Must have strong content knowledge of US and global submissions.
* In-depth knowledge of regulations and standards that apply to the development of medical devices a plus.
* Experience managing people and acting as a regulatory resource to internal and external clients.
* Effective communication skills both verbal and written, and strong ability to interact with other departments and external organizations
* Ability to manage multiple projects and complex timelines in a team environment
* Ability to act as head of Regulatory Affairs department as needed and lead company wide initiatives.
General Requirements: Job Family Responsibilities:
Provide advice and counsel to customers and technology partners on very complex matters; Develop and maintain complex business relationships with key decision makers in the Executive and Legislative branches of the U.S. Government; communicate company initiatives and technology programs to government representatives; Analyze and communicate company/government plans/activities, current market and competitive trends; recommend specific action to achieve goals; Develop and implement strategies targeting federally cooperatively funded programs; develop plans, negotiations, and proposals promoting technology development contracts; Represent the company in industry association activities
Education:
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Knowledge and Experience:
Demonstrates and applies advanced knowledge of concepts, practices, and procedures for area managed and basic knowledge of other areas in the company and how they interact. Demonstrates understanding and application of management approaches for work direction, motivation, performance management, and disciplinary action.Typically 8+ years of successful experience in a directly related field and successful demonstration of Key Responsibilities and Knowledge as presented above.
Direction of Others:
Typically manages multiple levels of exempt employees and/or supervisors.
Key Working Relationships:
Frequent inter-organizational and external contacts.
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