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Regulatory Affairs Manager - Carpinteria, United States - Freudenberg Group
Description
Regulatory Affairs Manager page is loadedRegulatory Affairs Manager
Apply
locations
United States of America - Remote
Carpinteria, CA
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
R_
Empowering people, creating technology.
Responsibilities:
Provide regulatory excellence to the organization and guide decision making
Responsible to direct, coordinate and supervise activities of Regulatory Affairs
staff. Establish
project priorities, ensure resources are available and balanced.
Regulatory lead/representative on project core teams (new product development, manufacturing, obsolescence, new suppliers, etc.) providing regulatory input on all matters
Reviews regulatory impact assessments drafted by RA staff for manufacturing and product changes for notification to regulatory agencies
Prepares regulatory plans and prepares needed regulatory submissions and associated documents for FDA, Health Canada, MDR, Notified Bodies, and ROW countries and secure approvals
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
Ensures RA staff prepares and maintains technical files as necessary to obtain and sustain product approvals
Work remote from home office in Pacific Time zone, willingness and ability to travel to Carpinteria, CA, per business need
Qualifications:
BS degree (preferably in Regulatory Sciences/Practices, etc.) or equivalent experience with RA coursework/seminars
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,
Knowledge of global regulatory requirements.
Proven track record with regulatory submissions.
Experience with leading a team.
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.
Freudenberg Medical LLCAbout Us
Welcome to Freudenberg
Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly.
And 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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