Job Description
We are seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our organization, you will play a critical role in maintaining and upholding our regulatory profile with various authorities.
Your primary responsibility will be to ensure that all products comply with relevant regulations and laws governing their importation, sale, and distribution.
* Develop, drive, and monitor the company's regulatory plans and procedures.
* Provide strategic and technical advice to senior management.
* Train and develop internal talent in the regulatory area.
You will also be responsible for managing key relationships with regulatory bodies and supporting audits.
Key Responsibilities
Regulatory Compliance:
* Ensure all products meet regulatory requirements.
* Prepare and submit product registration submissions and change notifications within agreed timelines.
Strategic Advice:
* Develop and implement regulatory strategies to support business growth.
* Collaborate with cross-functional teams to achieve regulatory compliance.
People Development:
* Train and develop internal talent in regulatory affairs.
* Mentor colleagues to enhance their knowledge and skills.
Relationship Management:
* Build and maintain effective relationships with regulatory authorities and industry partners.
* Support audits and provide timely responses to queries.
Requirements
To succeed in this role, you will need:
* Bachelor's degree or higher in a relevant field.
* 5+ years of experience in regulatory affairs, preferably in IVD or medical devices.
* Strong knowledge of regulatory statutes and industry standards.
* Excellent analytical, communication, and problem-solving skills.
* Ability to work independently and as part of a team.
Benefits
As a valued member of our team, you will enjoy:
* Flexible working arrangements.
* A competitive base salary and performance-based bonuses.
* Opportunities for professional growth and development.
About You
Are you a motivated and detail-oriented individual with a passion for regulatory affairs? If so, we would love to hear from you!