Regulatory Affairs Specialist

Job Description:
The Regulatory Affairs Specialistwill be responsible for establishing, coordinating, and executing user experience / design validations and related communications in support of Ormco Product Development. This position manages the design, study preparation, conducts, and close-out of clinical evaluations. This position establishes and manages internal systems to ensure that clinical evaluations meet all applicable regulations and guidelines, with strong focus on the new Medical Device Regulation (MDR) and FDA IRB studies. He or she coordinates design validation activities including site visits, compliance, and data management and analysis. He or she could also be involved in providing information and literature summaries to investigational sites to support studies and publications. This position will require someone on site 3 days per week in Brea.
Job Requirements:
PRIMARY DUTIES AND RESPONSIBILITIES:

• Identify and evaluate potential evaluators and establish strong relationships with clinical evaluation sites and staff.
• Manage all user experience/design validation interactions (including conduct site monitoring as needed, training, enrolment tracking, evaluation material and clinical supply requests) and ensure appropriate and timely communications are maintained in order to keep evaluations on-track.
• Assist with the design and implementation of strategies, plans, and practices for design validations.
• Develop and prepare key evaluation documents in conjunction with other team members (e.g. protocols, informed consents, amendments, monitoring plans, summary reports).
• Organize and participate in evaluators' meetings.
• Develop, edit and route user experience/design validation protocols.
• Work with QA, RA and R&D to insure compliance with protocols & evaluations.
• Assemble clinical packages to be sent to participating clinicians including NDAs, protocols, feedback forms & product.
• Keep in contact with clinical participants, receive feedback & photos, summarize information received and provide to the PM and/or project team.
• Prepare evaluation summary/progress reports necessary for DHF (PM provides input on conclusion and recommendations for next step in project)
• Attend all team meetings for projects that have or will have user experience/design validations.
• Attend & participate in company sponsored events (Forum, NSM, seminars) and AAO
• Other duties as assigned.

CRITICAL SUCCESS FACTORS:

• High intelligence and well-developed analytical skills
• Ability to think critically and in tactical and strategic dimensions simultaneously
• Lack of ego; team-first mentality
• Unquestionably high ethical standards and attention to reputational and compliance risks
• Ability to prioritize tasks in real time and exercise judgment
• Clear and organized communications skills (written and verbal)
• Analyse complicated issues and boil down to the key points, develop action plans and bring to a successful conclusion. Perseverance and consistency in pursuit of successful outcomes
• Will display and operate in a way that never compromises ethics and integrity, and will be non political in all dealings with agendas that are above board and understood by all; energy

QUALIFICATIONS:

• Bachelor's degree required; preferably in life sciences or a related scientific discipline.
• 3-4 years professional experience in clinical evaluation that are complaint to the new Medical Device Regulation (MDR) and/or FDA IRB studies within a product development environment.

PREFERRED:

• Background in the dental, healthcare, pharmaceutical or biotech industry preferred
• Must be highly organized and detail oriented
• Must possess outstanding interpersonal and communication skills (written and oral)
• Must be a hands-on team player, willing to do what it takes to get the job done
• Strong computer proficiency in MS Word, Excel, and PowerPoint.

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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.
$72,500 - $83,700
Operating Company:
Ormco
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.