Regulatory Affairs Specialist - Morrisville - Align Technology

Description

Overview

The Regulatory Affairs Specialist will be responsible for a wide variety of regulatory activities for sustaining products including medical devices and Software as Medical Device (SaMD) and regulatory operation. In addition, this role will be a global RA lead in product development cross functional team to lead global regulatory assessment for changes and support International registrations working with international RA affiliates. This role will assist or lead preparation of US, EU and Canada submissions for regulatory approvals, and license maintenance. This position also supports post market regulatory activities including regulatory operations and compliance, such as UDI, Non-Conformance, audit support, and process improvement.

• Lead or assist development and implementation of global regulatory strategy or product change impact assessment for Class I/II products in US, Canada, EU, UK, and support international regulatory assessment and registrations. Liaison between Align International RA affiliates and core functional team to provide global perspective. Reviews documents or engages in discussions to support international registrations
• Lead or assist preparation of regulatory submissions, technical documentation, and associated documents for registrations or license maintenance in the US, Canada, EU and UK.
• Assist regulatory operation to ensure regulatory compliance for audit readiness
• Collaborate with cross functional team or business partners to provide regulatory input to product lifecycle planning. Review product development documentation, labeling, claims and advertising promotional materials to ensure regulatory compliance or successful registrations.
• Regulatory liaison/representative in internal or external audits
• Keeps abreast of existing and emerging regulations, standards, and guidance documents related to Align products. May conduct impact assessment, or interpretive assistance.
• Compiles and maintains regulatory documentation databases and tracking systems as necessary
• May lead Regulatory initiatives to improve efficiency or address gaps in process
• May support regulatory compliance or operation activities, including but not limited to recall, Non-Conformance, CAPA, audit, process improvement, country approval, distribution control, annual update, post market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.

Department

Quality

Location

US-North Carolina-Raleigh

Role expectations

• Lead or assist development and implementation of global regulatory strategy or product change impact assessment for Class I/II products in US, Canada, EU, UK, and support international regulatory assessment and registrations. Liaison between Align International RA affiliates and core functional team to provide global perspective. Reviews documents or engages in discussions to support international registrations
• Lead or assist preparation of regulatory submissions, technical documentation, and associated documents for registrations or license maintenance in the US, Canada, EU and UK.
• Assist regulatory operation to ensure regulatory compliance for audit readiness
• Collaborate with cross functional team or business partners to provide regulatory input to product lifecycle planning. Review product development documentation, labeling, claims and advertising promotional materials to ensure regulatory compliance or successful registrations.
• Regulatory liaison/representative in internal or external audits
• Keeps abreast of existing and emerging regulations, standards, and guidance documents related to Align products. May conduct impact assessment, or interpretive assistance.
• Compiles and maintains regulatory documentation databases and tracking systems as necessary
• May lead Regulatory initiatives to improve efficiency or address gaps in process
• May support regulatory compliance or operation activities, including but not limited to recall, Non-Conformance, CAPA, audit, process improvement, country approval, distribution control, annual update, post market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.

What We're Looking For

• Education: Bachelors Degree in a related technical, science or legal field. Masters degree in related field is preferred

Experience

• At least 2 years of regulatory experience in a medical device industry.
• Experience with EU MDR Technical Files and Design Control

Skills

• Skillful in computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint, PDF
• Skill or knowledge of applying AI tool in regulatory
• Solid understanding of Design Control requirements, FDA QSR regulations, and ISO 13485 MDSAP quality System Management
• Keen ability to prioritize work and execute in an environment of competing priorities. Excellent time and project management skills with the ability to multi-task
• Communication: Strong written and verbal communication skills with ability to effectively communicate at multiple levels in the organization
• Strong organizational, follow-up skills, as well as attention to detail.
• Being able to drive, coordinate with stakeholders and activities for tasks execution to deliver results, analyze or resolve issues
• Teamwork: Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team. Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Pay Transparency

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidates pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.

For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.

Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.

General Description Of All Benefits

We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.

Benefits

• Family Benefits. Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans. Align also offers to employees:
• Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
• Back-up Child/Elder Care and access to a caregiving concierge
• Family Forming Benefits Available to Employees, and their spouse or domestic partner, covered under one of Aligns health plans
• Breast Milk Delivery and Lactation Support Services
• Employee Assistance Program
• Hinge Health Virtual Physical Therapy Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan

Employee benefits. Align offers its employees:

• Short-term and long-term disability insurance in accordance with those plans.
• Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
• Flexible Spending Accounts Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
• 401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%.). Employer match vests after two years 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
• Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
• Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days. Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
• Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
• 11 Company-designated paid holidays throughout the year.
• If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave. All parental leave must be completed within one year of the birth or placement of the child. Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
• Non-exempt employees will receive full pay for up to 10 days of jury duty. Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.

To the extent applicable state or local law offers more generous benefits, Align complies with any such law.

Applicant Privacy Policy

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Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.