Regulatory Affairs Manager

** THIS IS AN ONSITE POSITION IN VALENCIA **

Reputable Medical Device company

Competitive Salary
Benefits (Medical/ Dental/ Vision)
PTO Package
401K
Bonus
Flexible work environment

** THIS IS AN ONSITE POSITION IN VALENCIA **

Job Details:
We are currently seeking a highly motivated, detail-oriented, and experienced Regulatory Affairs Manager to join our dynamic team in the medical device industry. This role requires a strategic thinker with a strong understanding of the regulatory landscape, who can lead and manage regulatory activities while ensuring compliance with local, national, and international regulatory standards. The Regulatory Affairs Manager will have the confidence and competence to make critical regulatory decisions and will be responsible for overseeing all aspects of regulatory affairs, including quality assurance, quality control, and compliance with ISO 13485, CA-RHB, cGMP, and CMDR. The successful candidate must have a minimum of 5+ years of experience in a similar role.

Responsibilities:

• Manage and oversee all regulatory affairs activities to ensure compliance with local, national, and international regulations and standards.
• Develop and implement regulatory strategies and processes to support the company's business objectives.
• Coordinate and prepare regulatory submissions for new products and product changes as required to ensure timely approvals.
• Maintain the company's quality system in compliance with ISO 13485, CA-RHB, cGMP, and CMDR.
• Oversee quality control and quality assurance activities, ensuring the highest standards are met.
• Manage CAPAs, CAPARs, SS&DRs processes to identify and address non-conformities and drive continuous improvement.
• Liaise with regulatory authorities and represent the company at regulatory meetings and inspections.
• Monitor changes in regulatory legislation and guidelines and implement necessary changes to maintain compliance.
• Provide regulatory guidance and training to cross-functional teams within the organization.

Qualifications:

• A minimum of 5+ years of experience in regulatory affairs in the scientific industry.
• Bachelor's degree in a scientific discipline, or equivalent. Advanced degree preferred.
• Proven experience in managing and implementing ISO 13485, CA-RHB, cGMP, and CMDR.
• Strong knowledge of quality control, quality assurance, CAPAs, CAPARs, and SS&DRs.
• Excellent strategic thinking, problem-solving, and decision-making skills.
• Ability to manage multiple projects and meet deadlines.
• Strong written and verbal communication skills.
• Ability to work cross-functionally and build relationships with internal and external stakeholders.
• Demonstrated leadership skills and the ability to influence at all levels of the organization.
• Strong understanding of the regulatory landscape and ability to interpret and apply regulatory guidelines.