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Sr Regulatory Affairs Spec Job Opening In Carlsbad – Now Hiring IntePros Consulting


Job description

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.

#LI-JA1

#LI-Remote

Required Skill Profession

Business Operations Specialists


  • Job Details

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Unlock Your Sr Regulatory Potential: Insight & Career Growth Guide


Real-time Sr Regulatory Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Sr Regulatory in Carlsbad, United States, highlighting market share and opportunities for professionals in Sr Regulatory roles.

56199 Jobs in United States
56199
52 Jobs in Carlsbad
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Download Sr Regulatory Jobs Trends in Carlsbad and United States

Are You Looking for Sr Regulatory Affairs Spec Job?

Great news! 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: .

The Work Culture

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:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying United States laws and regulations

What Is the Average Salary Range for Sr Regulatory Affairs Spec Positions?

The average salary range for a 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.

What Are the Key Qualifications for Sr Regulatory Affairs Spec?

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. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

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To improve your chances of getting hired for Sr Regulatory Affairs Spec, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

Interview Tips for Sr Regulatory Affairs Spec Job Success

IntePros Consulting interview tips for Sr Regulatory Affairs Spec

Here are some tips to help you prepare for and ace your Sr Regulatory Affairs Spec job interview:

Before the Interview:

Research: Learn about the IntePros Consulting's mission, values, products, and the specific job requirements and get further information about

Other Openings

Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

Dress Professionally: Choose attire appropriate for the company culture.

Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

During the Interview:

Be Punctual: Arrive on time to demonstrate professionalism and respect.

Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.

Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.

Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.

Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.

Follow Up: Send a thank-you email to the interviewer within 24 hours.

Additional Tips:

Be Yourself: Let your personality shine through while maintaining professionalism.

Be Honest: Don't exaggerate your skills or experience.

Be Positive: Focus on your strengths and accomplishments.

Body Language: Maintain good posture, avoid fidgeting, and make eye contact.

Turn Off Phone: Avoid distractions during the interview.

Final Thought:

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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