Job Description:
JOB SUMMARY:
The Regulatory Affairs Specialist (RA Specialist) creates, evaluates and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, special projects and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.
PRIMARY DUTIES & RESPONSIBILITIES:
- Regulatory professionals stay up to date with relevant regulations, including proposed and final rules issued by regulatory authorities. They understand how these regulations impact the company and thus must stay up to date and provide regulatory support as needed.
- Create procedures and standard operating procedures (SOPs) and technical documentation that link to regulatory operations. Clear documentation is essential for compliance.
- Assist in drafting Technical Files and accumulate technical documentation for global product registrations. They work closely with global registration teams to facilitate registrations for a large portfolio of products.
- Implement and coordinate regulatory strategies and plans from senior leadership. This involves ensuring timely product registrations in compliance with regulations and guidance.
- Prepare and maintain regulatory submissions, product registrations, certifications, and facility registrations. They follow country-specific requirements to facilitate product approvals in various regions.
- Work directly with distributors, in-country consultants, inter-company partners, and commercial partners to fulfill regulatory requirements for product registration.
- Review and assess product, manufacturing, and labeling changes for regulatory reporting impact and compliance.
- Be a strategic partner who can help navigate complex compliance landscapes and ensure timely product registrations worldwide.
- Follow Envista CIRCL values. Incorporate CIRCL values into daily work. Be customer centric and build ethical, supportive relationships with customers.
Job Requirements:
- Bachelor's Degree (BA/BS) from four-year college/university
- 3+ years of medical device experience, and/or training in an FDA-regulated industry, or equivalent combination of education and experience; or 2+ years regulatory experience with a master’s degree from a college/university.
PREFERRED QUALIFICATIONS:
- Advanced degree or RAC certification preferred.
- Master’s in Regulatory Science preferred.
- Demonstrated international submissions experience (i.e., APAC, LATAM, Australia TGA, Health Canada, and/or EU Technical files a plus).
SKILLS/QUALIFICATIONS:
- Be respectful of peers. Open-minded and willing to take an educated risk, fail fast and try again.
- Ability to challenge the status quo and seek opportunities to set new standards.
- Ability to take accountability of his/her work, good or bad. Takes initiative to make a positive difference and win with our customers and co-workers.
- Maintains a 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 be flexible and adaptable. Know when to ask questions. Have a positive attitude. Demonstrate a commitment to getting the job done right and on time.
- Be able to successfully manage multiple projects and product families.
- Must be comfortable dealing with ambiguity, relying on critical thinking to accomplish project goals
- Maintain a professional demeaner under pressure. Begin to demonstrate problem-solving skills and creativity. Ability to persuade coworkers in a positive, partnership perspective.
- Be able to see the big picture and how your projects fit into corporate goals and objectives.
- 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.
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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.
$80,200 – $120,400
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.
