Regulatory Affairs Specialist I at Freudenberg Group

Working at Freudenberg: We will wow your world!

Responsibilities:

• Performs regulatory impact assessments for manufacturing and product changes for notification to regulatory agencies

• Prepares regulatory plans, prepares needed regulatory submissions and maintains associated documents for FDA, Health Canada, MDR, Notified Bodies, and ROW countries and secure approvals

• Go to person for cross functional team to elaborate and align on regulatory tasks and required documentation

• Conducts training programs to educate employees on regulatory processes and requirements

• Communicates with regulatory agencies regarding clarification of and follow-up of submissions under review

• Assesses product, manufacturing and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance to regulations.

• Reviews technical reports for incorporation into regulatory submissions

• Maintains company registration and device listings for global regulatory agencies

• Regulatory liaison/representative in internal and external audits

• Maintains current knowledge base of existing and emerging regulations, standards and guidance documents

• Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings

• Prepares and maintains technical files as necessary to obtain and sustain product approvals

• Management of international standards, directives and regulations for gap impact analysis. This includes implementation of procedural and documentation updates, when necessary.

Qualifications:

• BS degree (preferably in Regulatory Sciences/Practices, etc.) or equivalent experience with certified RA coursework/seminars

• 3 - 5 years of medical device Regulatory Affairs experience with a track record of successful submissions

• Experience preparing & defending regulatory submissions to the FDA (510(k), Qsubs, IDE’s, EU MDR technical files,

• Detailed knowledge of global regulatory requirements.

• Proven track record with regulatory submissions.

• Energetic, positive self-starter with a strong proficiency to self-manage and work collaboratively in a high-performing team and cross-functional fast-paced environment

• Outstanding written and verbal communication skills

• Keen ability to prioritize work and execute in an environment of competing priorities

• Strong organizational skills

• Strong technical/computer skills

• Willingness and ability to travel to Carpinteria, CA, per business need about 25%

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.