Ink Technician

NEW Regulatory Manager Opportunity-Medical Device!

This Jobot Job is hosted by : Audrey Block

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Salary : $200,000 - $250,000 per year

A bit about us :

We are a well established consulting firm that provides solutions to medical device company, 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-lots of growth!

People management if interested

Strong benefits and compensation package

Opportunity to work in multiple therapeutic and diagnostic areas

Job Details

Job Details

We are currently seeking a dynamic, highly motivated, and experienced individual to join our team as an AD / Director of Regulatory Affairs in the Medical Device / Pharma industry. This is a pivotal role that will be responsible for the development and implementation of global regulatory strategies, ensuring compliance with applicable regulations and standards, and fostering positive relationships with regulatory agencies. The ideal candidate will have extensive experience with the FDA, Quality Assurance, and a deep understanding of the medical device industry. This position requires a minimum of 6+ years of experience 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 national and international regulations, standards, and guidance related to our products and operations.

3. Oversee all regulatory submissions including 510ks, PMAs, INDs, NDAs, BLAs, and MAAs.

4. Foster positive relationships with regulatory agencies, acting as the primary liaison for the company on all regulatory matters.

5. Collaborate with cross-functional teams to ensure that regulatory strategies are integrated into project plans.

6. Identify, assess, and communicate regulatory risks and mitigation strategies.

7. Oversee and manage the Quality Assurance function, ensuring that our products meet the highest standards of quality and safety.

8. Stay abreast of changes in regulatory legislation and guidelines, advising on the potential impact on the business.

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 in the medical device industry, with a strong focus on FDA interactions and Quality Assurance-strong PMA experience is required!!

3. Proven track record in the successful development and implementation of regulatory strategies and submissions.

4. Deep knowledge of national and international regulatory guidelines and legislation.

5. Exceptional leadership and project management skills.

6. Excellent communication and negotiation skills, with the ability to effectively liaise with regulatory agencies.

7. Strong problem-solving and decision-making abilities, with a focus on strategic and critical thinking.

8. Proficiency in using regulatory information management systems.

9. Ability to work collaboratively in a fast-paced, dynamic 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 provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.