What are the responsibilities and job description for the Regulatory Affairs Specialist position at Augment Jobs?
Job Title: Regulatory Affairs Specialist
Company: Augmentjobs
Salary Range: $80,000 to $120,000
Experience Level: 2-5 years
Job Description
As a Regulatory Affairs Specialist at Augmentjobs, you will be a key player in ensuring that our products and services comply with all relevant regulations and standards. You will work closely with various departments to manage regulatory submissions, maintain compliance, and stay up-to-date with changes in regulatory requirements.
Key Responsibilities
To apply for this position, please submit your resume and cover letter detailing your relevant experience and why you are a great fit for Augmentjobs.
Augmentjobs is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Company: Augmentjobs
Salary Range: $80,000 to $120,000
Experience Level: 2-5 years
Job Description
As a Regulatory Affairs Specialist at Augmentjobs, you will be a key player in ensuring that our products and services comply with all relevant regulations and standards. You will work closely with various departments to manage regulatory submissions, maintain compliance, and stay up-to-date with changes in regulatory requirements.
Key Responsibilities
- Regulatory Compliance: Ensure that all products, processes, and documentation comply with federal, state, and international regulations.
- Regulatory Submissions: Prepare and submit regulatory documents, including applications, reports, and correspondence to regulatory agencies.
- Documentation Management: Maintain accurate records of regulatory submissions, approvals, and correspondence. Ensure that documentation is up-to-date and accessible.
- Regulatory Strategy: Develop and implement regulatory strategies in collaboration with cross-functional teams to support product development and market entry.
- Regulatory Monitoring: Monitor changes in regulations and standards relevant to the company’s operations. Advise on the impact of these changes and implement necessary adjustments.
- Cross-functional Collaboration: Work with R&D, Quality Assurance, Marketing, and other departments to ensure compliance with regulatory requirements throughout the product lifecycle.
- Audit Preparation: Prepare for and participate in regulatory audits and inspections. Address any issues or findings promptly and effectively.
- Training and Guidance: Provide training and guidance to internal teams on regulatory requirements and best practices.
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field. Advanced degree is a plus.
- Experience: 2-5 years of experience in regulatory affairs or a related field, preferably within the industry.
- Knowledge: Strong understanding of regulatory requirements and processes, including FDA, EMA, and other relevant regulatory bodies.
- Skills:
- Excellent written and verbal communication skills.
- Strong attention to detail and organizational skills.
- Ability to analyze and interpret regulatory guidelines and standards.
- Proficiency in regulatory submission software and tools.
- Personal Attributes:
- Ability to work independently and as part of a team.
- Strong problem-solving skills and the ability to handle multiple tasks simultaneously.
- Proactive and adaptable to a fast-paced work environment.
- Competitive salary and performance-based bonuses
- Health, dental, and vision insurance
- 401(k) plan with company match
- Paid time off and holidays
- Professional development opportunities
To apply for this position, please submit your resume and cover letter detailing your relevant experience and why you are a great fit for Augmentjobs.
Augmentjobs is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary : $80,000 - $120,000
Senior Regulatory Affairs Specialist - Hybrid
7107 C.R. Bard, Inc. (Cov Ledger) -
Covington, GA
Senior Specialist, US Regulatory Affairs Operations
cyberThink Inc -
Athens, GA
Regulatory Affairs Specialist II – Heart Failure (on-site)
3205 St. Jude Medical, Cardiology Division, I -
Atlanta, GA
