Urgent! Sr Regulatory Affairs Spec Job Opening In Carlsbad – Now Hiring IntePros Consulting
Sr Regulatory Affairs Specialist
Contract Role
W2 only
Remote for the right candidate - West coast only
HM's Top Needs:
1.
minimum 3 years direct experience in international registration
2.
time management and project management skills, and abilities of quickly learning how to navigate the Medtronic systems and maintain registration database/tracker in a timely manner
3.
understanding of business urgencies and priorities
Education Required: Bachelor of Engineering/Science as minimum; Master preferred
Years’ Experience Required: 4-5 years as independent RA specialist in US/EU/Global registration
Top 3 technical skills or experience required?
Good time management and project management
Experience on global regulatory strategies and working with RA teams in different regions for product registration
Familiar with medical device design control process and follow up with design/manufacturing sites on additional documents required by global regulations
*We will consider fully remote candidate, however, would prefer anyone in pacific or mountain time
Responsibilities may include the following and other duties may be assigned.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty.
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
May act as a mentor to colleagues or may direct the work of other lower level professionals.
The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management.
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
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Unlock Your Sr Regulatory Potential: Insight & Career Growth Guide
Real-time Sr Regulatory Jobs Trends in Carlsbad, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Sr Regulatory in Carlsbad, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 56199 jobs in United States and 52 jobs in Carlsbad. This comprehensive analysis highlights market share and opportunities for professionals in Sr Regulatory roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! IntePros Consulting is currently hiring and seeking a Sr Regulatory Affairs Spec to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Sr Regulatory Affairs Spec Jobs Carlsbad.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at IntePros Consulting adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Sr Regulatory Affairs Spec Jobs United States varies, but the pay scale is rated "Standard" in Carlsbad. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Sr Regulatory Affairs Spec typically include Business Operations Specialists and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Sr Regulatory Affairs Spec interview at IntePros Consulting, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the IntePros Consulting's products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
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