Address
Form of work
SalaryEmpowering 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 LLC
