Freudenberg Group
Regulatory Affairs Specialist I
Freudenberg Group, Carpinteria, California, us, 93014
Regulatory Affairs Specialist ILocation: Carpinteria, CA, United States of America - RemoteTime Type: Full timePosted on: Posted 4 Days AgoJob Requisition ID: R_00074684Working 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, submissions, and maintains associated documents for FDA, Health Canada, MDR, Notified Bodies, and ROW countries to secure approvals.
Acts as the go-to person for cross-functional teams 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 and follow-up of submissions under review.
Assesses product, manufacturing, and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance with regulations.
Reviews technical reports for incorporation into regulatory submissions.
Maintains company registration and device listings for global regulatory agencies.
Serves as regulatory liaison/representative in internal and external audits.
Maintains current knowledge of existing and emerging regulations, standards, and guidance documents.
Identifies relevant guidance documents, international regulations, and standards, providing interpretive assistance for new filings.
Prepares and maintains technical files as necessary to obtain and sustain product approvals.
Manages international standards, directives, and regulations for gap impact analysis, including implementation of procedural and documentation updates when necessary.
Qualifications:
BS degree (preferably in Regulatory Sciences/Practices) 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 and 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 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, as needed, about 25%.
The Freudenberg Group is an equal opportunity employer committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to any characteristic protected by applicable law.About Us
Welcome to FreudenbergWithout Freudenberg, indoor air would not be as clean, cars would not drive, and wounds would not heal as quickly. These are just three examples from thousands of our applications.Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier, and more comfortable but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
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Performs regulatory impact assessments for manufacturing and product changes for notification to regulatory agencies.
Prepares regulatory plans, submissions, and maintains associated documents for FDA, Health Canada, MDR, Notified Bodies, and ROW countries to secure approvals.
Acts as the go-to person for cross-functional teams 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 and follow-up of submissions under review.
Assesses product, manufacturing, and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance with regulations.
Reviews technical reports for incorporation into regulatory submissions.
Maintains company registration and device listings for global regulatory agencies.
Serves as regulatory liaison/representative in internal and external audits.
Maintains current knowledge of existing and emerging regulations, standards, and guidance documents.
Identifies relevant guidance documents, international regulations, and standards, providing interpretive assistance for new filings.
Prepares and maintains technical files as necessary to obtain and sustain product approvals.
Manages international standards, directives, and regulations for gap impact analysis, including implementation of procedural and documentation updates when necessary.
Qualifications:
BS degree (preferably in Regulatory Sciences/Practices) 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 and 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 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, as needed, about 25%.
The Freudenberg Group is an equal opportunity employer committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to any characteristic protected by applicable law.About Us
Welcome to FreudenbergWithout Freudenberg, indoor air would not be as clean, cars would not drive, and wounds would not heal as quickly. These are just three examples from thousands of our applications.Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier, and more comfortable but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
#J-18808-Ljbffr