Sr. Regulatory Affairs Specialist - Remote Job at Freudenberg Medical LLC
Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments. The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,000 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,000 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.
Responsibilities
- Regulatory lead on project core teams (new product development, manufacturing, obsolescence, new suppliers, etc.) providing regulatory input on all matters
- Drive regulatory support for currently marketed products including reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory bodies (FDA, Health Canada, Notified Bodies, and ROW countries) and secure approvals
- Communicate with regulatory agencies regarding clarification of and follow-up of submissions under review
- 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
- Prepares and maintains technical files as necessary to obtain and sustain product approvals
- Apply technical or regulatory principles, theories and concepts.
- Keep current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas
- Provide mentoring and support to other members of the department
Qualifications
- Bachelor's Degree and a minimum of 3 years of experience in regulatory affairs in the medical device industry
- Must have a minimum of 5 years regulatory experience with medical devices.
- Willingness and ability to travel to Carpinteria, CA approximately once a month
- Experience preparing & defending regulatory submissions to the FDA (510(k), Qsubs, IDE’s, etc. are particularly preferred)
- Proven experience and success with FDA in both audit and submission categories
- Proven experience and success in dealings with Notified Bodies, Competent Authorities, Authorized Representatives
- Managerial experience supervising direct reports, preferred
- Thorough knowledge of FDA medical device regulations
- Thorough knowledge of ISO quality system and CE medical device standards, guidelines and directives
- Proficiency in Word, Excel, Power Point
- Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team
- Outstanding written and verbal communication skills
- Keen ability to prioritize work and execute in an environment of competing priorities
- Strong organizational and technical/computer skills
Some of your Benefits
401K Match: Save for retirement with the company's help
Diversity & Inclusion: Enter a diversity-driven world of innovation
Flexible work arrangements: Opportunities for flex hours and/or remote work to maximize performance satisfaction
Sustainability / Community service: Making a difference with sustainability, community service
Company events: Events to built teams and relationships prime for accomplishment
Additional Information
Rachel Peterson
#LI-MEDICAL
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