Job Description:
The Regulatory Affairs Specialist II creates, evaluates and completes regulatory tasks related to 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.
This position is required to be on-site at least four days a week.
PRIMARY DUTIES & RESPONSIBILITIES:
- Assemble and maintain CE technical files in accordance with applicable regulatory requirements.
- Author, review, and approve Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and Post-Market Surveillance (PMS) reports.
- Monitor and interpret regulatory changes, including proposed and final rules issued by global regulatory authorities, and assess their impact on company operations.
- Develop and maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations.
- Collaborate with global registration teams to support product registrations across a diverse portfolio, ensuring alignment with country-specific requirements.
- Implement and coordinate regulatory strategies and plans as directed by senior leadership, ensuring timely and compliant product registrations.
- Prepare, submit, and maintain regulatory submissions, product registrations, certifications, and facility registrations for global markets.
- Liaise with distributors, in-country consultants, inter-company partners, and commercial teams to fulfill regulatory requirements for product registration and compliance.
- Review and evaluate product, manufacturing, and labeling changes to determine regulatory reporting obligations and ensure continued compliance.
- Serve as a strategic regulatory partner, providing guidance on complex compliance landscapes and facilitating global product approvals.
- Uphold and integrate Envista CIRCLe values into daily work, fostering customer-centric and ethical relationships with internal and external stakeholders.
- Stay informed of new regulatory developments by reviewing relevant publications and industry updates.
- Perform special projects and assignments as directed by Manager.
Job Requirements:
QUALIFICATIONS:
- Bachelor's Degree
- 2+ years of Regulatory Affairs experience in medical devices or other regulated industry. We will also consider a Master’s Degree with 1+ years of Regulatory Affairs experience in medical devices or other regulated industry.
- Strong working knowledge of the European Medical Device Regulation (EU MDR), including demonstrated experience with Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS), and Periodic Safety Update Reports (PSUR).
PREFERRED:
- 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/ABILITIES:
- 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.
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. While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. 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. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.
- 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.
$85,800 - $104,800
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.
