Regulatory & Compliance Specialist

Would you be excited to work at a company that consistently creates the top performing products in its category? To help grow a brand already loved by millions of customers worldwide?
We are looking for a Regulatory and Compliance Specialist to join our Operations team from our satellite office in Malmö, Sweden who can take the lead in ensuring that Frida´s operations adhere to the laws regulating the CPG and medical device industries globally. The right person will have knowledge of medical devices, cosmetics, and consumer goods regulations in the EU. The Regulatory and Compliance Specialist will report to the Sr. Director of Supply Chain (based at our HQ in Miami, FL) and will focus on auditing product compliance, resolving compliance issues, staying abreast of regulatory changes, and liaising with outside parties to ensure compliance in global markets.
Core Responsibilities:

• Manage the quality & compliance of existing products and service expectations in the EU
• Manage specifications for new products and existing products adapted for the EU to ensure compliance throughout product life
• Ensure that the internal regulatory database for new products is kept updated with back up information for all specifications to ensure that all necessary paperwork is available for labeling and registration
• Ensure that all paperwork and SOPs are established to streamline production site registrations and qualification processes
• Assist in Annual Product Review and ensure that any procedural revisions are communicated to the manufacturing facilities and that training is conducted
• Monitor performance against quality standards and champion suggestions for continuous improvement
• Quality agreement negotiation & maintenance, deviation & investigation support, and CAPA follow-up
• Schedule & oversee routine and for-cause audits
• Draft corrective action responses associated with state, federal, international and customer audit observations
• Labeling compliance, following local labeling standards, coordinating the translation of legal and brand copy, proof reading, and approvals (internal and external)
• Coordinate with external parties (distributors, vendors, legal counsel, importers, authorities) to ensure that products are legally compliant and any required product registrations are valid

 
Preferred Qualifications:

• Bachelor´s degree in Science, Engineering, Pharmaceutical Science or another related field
• 1 year of progressively responsible quality related experience within the regulated medical device industry
• A minimum of 3 years of demonstrated experience resolving EU Health Authorities compliance and regulatory issues
• Prior experience in actively auditing products within the EU
• Highly organized, meticulous with a great attention to detail
• Able to work independently as well as in teams
• Result-oriented, creative and able to multi-task
• Able to see what is relevant, prioritize and ask the right questions
• Able to maintain confidentiality of records
• Great communication skills both verbally and written

 

About Frida

Based in Miami, FL USA with satellite offices in Malmö, Sweden and Los Angeles, California, Frida – home of Frida Baby and Frida Mom - is a rapidly growing millennial parenting brand of early-childhood and maternity products. With the #1 selling baby healthcare product on Amazon and in 35,000+ retail doors nationwide, Frida is a brand to watch. Frida receives consistent praise from doctors and the press, including Fast Company, Forbes, and Entrepreneur Magazine. In addition, Parents magazine named Frida´s CEO one of the top millennial moms to watch and Inc. Magazine recognized her in the Top 100 Female Founders list.

Besides being a company that makes incredible products for parents around the world, we believe in a work hard, play hard mentality.

We look forward to receiving your application no later than April 24, at www.badenochandclark.se or using link below. Selection and interviews will be ongoing and the position might be filled before the last day of application.

This process is in collaboration with Badenoch + Clark.
For any questions regarding this position, please reach out to Senior Consultant Matilda Rodey at 0736 84 74 50 or matilda.rodey@badenochandclark.se