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Implant Direct is part of Envista’s portfolio of dental product and service companies, including more than 30 trusted brands and over 125 years of dental excellence.  With over 4.6 million implants placed worldwide, Implant Direct enables dentists to advance their patients’ oral health with high-quality dental implant solutions. All implants are manufactured in the USA using only medical-grade titanium alloy, meeting the industry’s highest performance and safety standards.  We offer a unique portfolio of products and solutions that elevate the performance of your practice through predictable outcomes, greater patient satisfaction, and reduced total costs. We are committed to renewing confidence and changing lives through enhancing patient access. For more information about Implant Direct, visit www.Implantdirect.com

Job Description:

JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.)

ESSENTIAL DUTIES:

• Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, AU technical files, Japan, MEA and other countries as well as for human tissue bank products for US FDA and various States.

• Represent Regulatory Affairs on assigned project teams through all phases of product development, provide Regulatory Strategy and assess regulatory impact of changes on existing products

• Coordinate and prepare document packages for regulatory submissions to the US, EU, AU, and Canada [510(k) Pre-Market Notifications, Product Reports/Supplements, Tech Files, 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, AU technical files and international dossiers (Canada, Saudi Arabia, Japan, Egypt, Indonesia etc.), US Tissue Bank licenses, and Canada CTO licenses.

• 5Represent Regulatory Affairs on change controls and provide regulatory assessment. Review and approve marketing communication materials

• Provide guidance on global compliance, such as GMP and product registrations, clinical evaluations in accordance with US FDA, AU TGA, Canadian CMDCAS, MDSAP and ISO 13485,etc.

• Monitor regulatory and legislative environment and assess impact of new regulations and works with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes

• Provide 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,  international regulators, 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. 13. Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.

• Create and update departmental standard operating procedures (SOPs).

Job Requirements:

MINIMUM REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIRED EDUCATION AND/OR EXPERIENCE:

• Bachelor’s Degree (BA/BS) in Engineering, Life Sciences, or health care-related discipline required.

• Minimum five (5) years of experience in Medical devices regulatory submissions required.

• Experience with successful preparation and submission of 510(k) and international documents and registration and marketing of medical devices worldwide required.

LANGUAGE SKILLS: 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.

OTHER PREFERRED EDUCATION, SKILLS and ABILITIES:

• Experience with FDA, Health Canada and international regulators 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.

• Expert knowledge of US and international medical devices regulations, guidelines, and policies.

• 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 (SAP 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.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.  At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$87,700 – $102,300

Operating Company:

Implant Direct

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista’s internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.