Job Description
We are looking for a detail-oriented Regulatory Compliance Analyst to ensure our organization complies with all applicable regulations and standards. This role involves monitoring regulatory changes, analyzing compliance risks, and collaborating with cross-functional teams to implement solutions. The ideal candidate will have a strong analytical mindset and a solid understanding of regulatory frameworks in the medical device, pharmaceutical, or biotech industries.
Key Responsibilities:
- Monitor and analyze regulatory updates, guidelines, and standards relevant to the organization’s operations.
- Conduct compliance risk assessments and provide recommendations to address potential issues.
- Assist in the preparation and submission of regulatory filings and compliance reports.
- Collaborate with internal teams to develop and implement compliance policies and procedures.
- Support audits and inspections by regulatory authorities, ensuring all necessary documentation is prepared.
- Maintain compliance records and generate regular reports for management.
- Provide training and guidance to staff on compliance-related matters.
Qualifications:
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Business, or a related field.
- 2-4 years of experience in regulatory compliance or a similar role.
- Knowledge of regulatory frameworks such as FDA regulations, GMP, and ISO standards.
- Strong analytical and problem-solving skills.
- Excellent communication and organizational abilities.
- Proficiency in compliance management tools and software is a plus.
Benefits:
- Competitive salary and performance incentives.
- Comprehensive health, dental, and vision insurance.
- Opportunities for career development and training.
- A collaborative and dynamic work environment.
How to Apply:
Interested candidates should submit their resume and a cover letter outlining their experience in regulatory compliance and their qualifications for the role.