Lead Data Engineer

Society for Conservation Biology; Town of Texas (WI); Remote; USD 185,000 - 250,000; Full time

Job summary

A leading consulting firm is seeking an AD/Director of Regulatory Affairs in the Medical Device/Pharma industry. This role involves developing global regulatory strategies, ensuring compliance, and working closely with regulatory agencies. The ideal candidate will have extensive FDA experience and a strong background in Quality Assurance. Join a small company with growth opportunities and a strong benefits package.

Benefits

Strong benefits and compensation package

People management opportunities

Opportunity to work in multiple therapeutic and diagnostic areas

Qualifications

• Minimum of 6+ years of experience in Regulatory Affairs within the medical device industry.
• Strong FDA interactions and Quality Assurance experience.

Responsibilities

• Lead the development and execution of global regulatory strategies.
• Ensure compliance with all applicable regulations and standards.
• Oversee all regulatory submissions including 510(k)s, PMAs, INDs.

Skills

Leadership

Communication

Problem Solving

Decision Making

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

Regulatory information management systems

Job description

EW REMOTE AD/Director Regulatory Affairs Opportunity-Medical Device!

This Jobot Job is hosted by: Audrey Block

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary: $185,000 - $250,000 per year

A bit about us:

We are a well-established consulting firm providing solutions to medical device companies, pharmaceuticals, and biologics. We are looking for an AD/Director of Regulatory Affairs.

Why join us?

• Opportunity to wear different hats in a small company with lots of growth!
• People management opportunities if interested
• Strong benefits and compensation package
• Opportunity to work in multiple therapeutic and diagnostic areas

Job Details

We are seeking a dynamic, highly motivated, and experienced individual to join as an AD/Director of Regulatory Affairs in the Medical Device/Pharma industry. This pivotal role involves developing and implementing global regulatory strategies, ensuring compliance, and liaising with regulatory agencies. The ideal candidate will have extensive FDA experience, Quality Assurance expertise, and at least 6+ years in a similar role.

Responsibilities

1. Lead the development and execution of global regulatory strategies for product development and approval.
2. Ensure compliance with all applicable regulations, standards, and guidance.
3. Oversee all regulatory submissions including 510(k)s, PMAs, INDs, NDAs, BLAs, and MAAs.
4. Foster positive relationships with regulatory agencies, acting as the primary liaison.
5. Collaborate with cross-functional teams to integrate regulatory strategies into project plans.
6. Identify, assess, and communicate regulatory risks and mitigation strategies.
7. Oversee and manage the Quality Assurance function, ensuring product safety and quality.
8. Stay updated on regulatory legislation changes and advise on their impact.
9. Provide regulatory training and guidance to internal teams.

Qualifications

1. Bachelor's degree in a scientific discipline; advanced degree preferred.
2. Minimum of 6+ years of experience in Regulatory Affairs within the medical device industry, with strong FDA interactions and Quality Assurance experience, especially PMA.
3. Proven success in regulatory strategy development and submissions.
4. Deep knowledge of regulatory guidelines and legislation.
5. Exceptional leadership and project management skills.
6. Excellent communication and negotiation skills.
7. Strong problem-solving and decision-making abilities.
8. Proficiency in regulatory information management systems.
9. Ability to work collaboratively in a fast-paced environment.
10. Strong commitment to quality and attention to detail.

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Jobot is an Equal Opportunity Employer. We celebrate diversity and provide an inclusive work environment. All qualified candidates will receive consideration without regard to race, color, religion, age, sex, national origin, disability, veteran status, sexual orientation, gender identity, or any characteristic protected by law.

Sometimes, background checks are performed with your authorization. We consider qualified candidates with criminal histories in accordance with applicable laws.