Regulatory Affairs Manager

Working at Freudenberg: We will wow your world!

Responsibilities:

• Provide regulatory excellence to the organization and guide decision making in cross-functional settings as a player/ coach

• Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and balanced

• Regulatory lead/ representative for project teams (new product development, commercial, manufacturing, obsolescence, new suppliers, etc.) providing regulatory input and guidance

• Reviews & performs regulatory impact assessments for manufacturing and product changes for notification to regulatory bodies

• Creates and oversees regulatory plans and regulatory submissions and associated documents for FDA, Health Canada, MDR Notified Bodies, and ROW countries to secure approvals

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

• Communicates with regulatory authorities 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 to incorporate into regulatory submissions

• Maintains company registration and device listings for global regulatory bodies

• Regulatory liaison/ representative for 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

• Manages preparation and maintenance of technical files as necessary to obtain and sustain product approvals

Qualifications:

• 5+ years of medical device Regulatory Affairs experience with a track record of successful submissions to FDA and MDR

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

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

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

• Strong knowledge and expertise of global regulatory requirements

• Proven track record of regulatory submissions specifically for FDA and MDR

• Strong leader to support and develop teams and colleagues

• Player/ coach who gets things done and performs well in a dynamic environment

• Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing cross-functional team

• 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

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.