Job Description:
The Regulatory Affairs Specialist is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory compliance with the goal of achieving notified body approval. This individual will also track marketing clearances/approvals, licenses, and applications for products to support sustainment projects and new product launches.
Job Requirements:
PRIMARY DUTIES & RESPONSIBILITIES:
- Work on ad-hoc projects when required.
- Request Certificate of Foreign Government and Certificates of Free Sale
- Resolve regulatory issues and ensure companywide compliance.
- Reviews regulatory publications to keep apprised of new regulatory developments.
- Performs special projects at the direction of the Regulatory Affairs Management.
- Responsible for assembling an CE technical file.
- Responsible for authoring, and or reviewing CER, SSCP, PSUR, and PMS reports.
- Works in partnership with manufacturing and RA/QA in designing and enhancing quality management systems to facilitate overall regulatory compliance.
- Responsible for authoring department standard operating procedure (SOPs).
- Responsible for FDA/Canadian device/drug establishment registrations and device/drug listings (as required).
- Responsible for assisting in regulatory review of product claims and literature.
- Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs.
- Assists with Customs requests.
- Responsible for global submissions (as required).
- Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: FDA, HC, EU and ROW).
- Provide regulatory support for Health Authority submissions including but not limited to proofreading documentation.
- Organize and maintain files/folders/databases for all business units to support the integrity of RA documentation.
- Management of the RA department purchase credit card (p-card) and monthly reconciliation.
- Coordination and submission of all purchasing requests within the RA department.
- Order documents, subscriptions, articles, standards and other items.
- Provide support and coordination for regulatory shipments (UPS, etc.).
- Coordination of all notarization and authentication (legalization) efforts for business units done per country requirements.
- Work on ad-hoc projects when required.
- Request Certificate of Foreign Government and Certificates of Free Sale
- Resolve regulatory issues and ensure companywide compliance.
- Reviews regulatory publications to keep apprised of new regulatory developments.
- Performs special projects at the direction of the Regulatory Affairs Management.
- Any duties or projects assigned by Manager.
REQUIREMENTS:
- Bachelor's Degree (BA/BS) from four-year college/university
- 2+ years of medical device experience, and/or training in an FDA-regulated industry, or equivalent combination of education and experience; or 1+ years regulatory experience with a master’s degree from a college/university.
- Respectful of peers. Open-minded and willing to take an educated risk, fail fast and try again. Challenge the status quo and seek opportunities to set new standards.
- Accountable his/her work, good or bad. Takes initiative to make a positive difference and win with our customers and co-workers.
- Sense of urgency and attention to detail. Must have “can do” attitude and be a team player.
- Proven ability to prioritize assigned projects and manage time effectively to meet all deadlines.
- Ability to understand technical product information
- Must have an above average understanding of the European MDR regulation, and CER, SSCP, PMS, and PSUR reports.
- Must have the ability to assemble a CE technical file.
PREFERRED QUALIFICATIONS:
- Experience with the registrations of orthodontic medical devices in the global market is a plus
- Has built processes and procedures contributing to regulatory strategy
- Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision
- Demonstrated organizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suite, databases and electronic document management systems
- Enthusiastic self-starter with excellent verbal, written, and interpersonal skills
- Highly organized, detail-oriented “mindset” and ability to be flexible and multi-task in a dynamically changing environment
- The ability to interpret and provide guidance on regulations from various countries
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
- Ability to write routine reports and correspondence.
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 sit.
- Frequently required to walk
- Occasionally required to stand
- Occasionally lift and/or move up to 25 pounds
- Quite to moderate noise level 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.
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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.
$42,300 – $63,400
Operating Company:
Ormco
Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.
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.
