Danaher Corporation Sr. Regulatory Affairs Specialist in Thousand Oaks, California
Danaher Company Description
Implant Direct is one of the fastest growing major dental implant companies in the world today. We’re one of the many operating companies within Danaher Corporation’s dynamic portfolio of dental companies.
Implant Direct operates a state of the art manufacturing facility in Thousand Oaks, California. We manufacture and distribute a broad range of value priced surgical, prosthetic and regenerative solutions to dental professionals in the US, Canada, and around the globe. We design and develop products which make high quality implants more accessible to patients around the world. We educate dentists on how to place implants and improve their patient care.
If you are interested in working in a lean, fast moving, entrepreneurial environment where you can learn, grow and make a difference, join us at Implant Direct.
JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, EU, China, Brazil, etc.)
* Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, EU technical files, Brazil, Russia, India, China, Japan, and other countries.
* Support UDI and GUDID database operations.
* Monitor impact of changing regulations on submission strategies.
* Coordinate and prepare document packages for regulatory submissions to the US, EU, and Canada [510(k) Pre-Market Notifications, Product Reports/Supplements, CE Mark, Health Canada].
* Responsible in the preparation and compilation of domestic and international product registration submissions. This includes, but is not limited to Pre-Market Notifications, 510ks, CE technical files and international dossiers (Canada, China, Brazil, Australia, Japan Russia, India, etc…).
* Represent Regulatory Affairs on assigned project teams through all phases of product development and provide Regulatory Strategy.
* Represent Regulatory on change controls and provide regulatory assessment.
* Provide guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex II and Annex VII and ISO 13485, Canadian CMDCAS, etc.
* Providing information and materials for Certificate to Foreign Governments (CFG), and medical device listings for FDA.
* Participate in the planning, conduct, and reporting for external audits (FDA, Notified Body, CFDA, KFDA, etc.) as requested.
* Participate, as assigned, as a CAPA owner, team member, or “task” owner.
* Work with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes.
* Direct communication with regulatory authorities regarding company’s regulatory filings. * Remain current on developments in field(s) of expertise, regulatory requirements and industry * trends. Create and update departmental standard operating procedures (SOPs).
REQUIREMENTS: * Bachelor's Degree (BA/BS) in Engineering, Life Sciences, or health care-related discipline. * Minimum five (5) years of experience in regulatory submissions. * Experience with successful preparation and submission of 510(k) and international documents and registration and marketing of medical devices worldwide. PREFERRED SKILLS/EXPERIENCE: * Experience with Health Canada and EU technical files is strongly preferred. * Advanced degree and/or Regulatory Affairs Certification (RAC) preferred. * Ability to clearly communicate and write reports and business correspondence in English. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism. * Experience in supporting international registrations. QUALIFIED CANDIDATE WILL POSSESS: * Expert knowledge of US and international submissions regulations, guidelines, and policies and regulations. * Excellent working knowledge of medical device regulations (21CFR) and FDA law. * Experience in design control process. * Expert at compiling medical device documents into clear, easy-to-understand submissions packages. * Expert at writing, reviewing and editing technical documents. * Highly effective at working with cross-functional teams from diverse disciplines and culture. * Must be able to negotiate internally and externally with regulatory agencies. * Identify, communicate and solve regulatory issues with project reams and management. * Strong organizational skills. * Ability to read, understand and retain extensive working knowledge of procedures and company documents. * Excellent MS-Office Applications. * Knowledge of computer files management software (QCBD preferred) * Able to produce positive results with a strong sense of urgency and ability to multi-task. * Strong interpersonal and presentation skills. * Knowledge of Quality System Requirements and Standards.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls. The employee frequently is required to climb stairs, sit, walk, stand, reach with hands and arms, talk and hear.
The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
Implant Direct Sybron Manufacturing, LLC is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Implant Direct
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Thousand Oaks
Req ID: IMP000618