Regulatory Affairs Specialist

Job Description

Job Description

Position Overview:
The Regulatory 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
• 1+ years of medical device experience, and/or training in an -regulated industry
• 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. 

 

Pay Details: $35.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to -us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.