Regulatory Affairs Lead

Key Accountabilities

• Prepare the required documentation to obtain the CE mark, FDA, or other country registrations for the company’s manufactured products or customer’s products in accordance with current legislation. Communication and maintenance of products with Spanish authorities.

• Support customers with any regulatory aspect.

• Follow up and resolve requirements that emerge during registration procedures.

• Maintain technical files as necessary to sustain product approval.

• Review product materials, labeling, and/or specification sheets for compliance with applicable regulations and customer policies.

• Be part of CFT projects as the RA representative.

• Support internal and external audits, validations, and product risk analysis.

• Follow management indicators/metrics for the proper performance of the department and apply appropriate corrective actions if necessary.

• Support the Market Surveillance Department in compiling information for Post-Market Surveillance.

• Recommend and manage, if applicable, changes to company procedures/documents (quality system and compliance) to comply with current regulations, guidelines, and/or standards.

• Provide support to Customer Service regarding product import/export.

• Ensure effective partnering and collaboration with R&D, Quality Operations, Design Quality, and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.

• Ensure all documentation is RA-reviewed before it is shared externally with regulators and/or customers.

• Collaborate with other QRA groups, R&D, and Operations to ensure successful Regulatory Inspections.

Internal Networking

To be determined based on department needs, to include interactions such as:

• All departments of the company.

• Werfen Companies.

• Customers.

• Regulatory agencies.

• Suppliers.