[{"_1":2,"_3":-5,"_4":-5},"loaderData",{"_5":6,"_7":8},"actionData","errors","routes/ssr/_anon-layout",{"_330":331,"_332":333,"_334":-5,"_335":336,"_337":338,"_339":340,"_341":342},"browse-city",{"_9":10,"_11":12,"_13":14,"_15":16,"_17":18,"_19":20,"_21":22,"_23":24,"_25":26,"_27":28,"_29":30,"_31":32},"careerAreaSlug","law-and-public-safety","careerAreaName","Law & Public Safety","occupationSlug","regulatory-affairs-manager","occupationName","Regulatory Affairs Manager","stateSlug","nc","stateName","North Carolina","citySlug","morrisville","cityName","Morrisville","jobs",[313],"gone",false,"selectedJobDetail",{"_36":37,"_38":39,"_40":41,"_42":43,"_44":45,"_46":47,"_48":49,"_50":51,"_52":53,"_23":54,"_19":20,"_55":28,"_56":57,"_58":59,"_60":61,"_62":63,"_64":65,"_66":67,"_68":28,"_69":70,"_71":70,"_72":28,"_73":28,"_74":75,"_76":77,"_78":79,"_80":28,"_81":28,"_82":83,"_84":85,"_86":87,"_88":89,"_90":91,"_92":93,"_94":95,"_96":97,"_98":99,"_100":101,"_102":103,"_104":105,"_106":28,"_107":108,"_109":110,"_21":22,"_17":18,"_13":14,"_111":112,"_9":113,"_114":115,"_116":117,"_118":119,"_120":121,"_122":123,"_124":125,"_126":70,"_127":37,"_128":39,"_129":112,"_130":131,"_132":133,"_134":135,"_136":137},"selectedJobCompanyDetails",{"_33":34,"_35":34},"profileURL","","CompanyName","id","0b1aa9e0017a690c2b0280a59cf6386fb4a80834","slug","sr-manager-regulatory-affair-0b1aa9e0","title","Sr. Manager, Regulatory Affairs","body","Description The Sr. Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global standards. The devices in scope include physical devices, software in medical device (SiMD) and software as a medical device (SaMD). In particular, this role will (a) provide strategic device regulatory decisions on strategies and risk management of the diagnostic device and AI/ML product portfolio throughout the entire product lifecycle, (b) solve unique and strategic challenges with broad impact on the growing diagnostic device portfolio in a dynamic regulatory environment, and (c) establish trusted relationships with industry partners and interface with health authorities with the goal to influence industry best practices and regulatory landscape intentionally. This position requires in depth and breadth of US device regulatory knowledge and experience throughout the product life cycle, strong leadership, critical thinking, collaboration and influencing skills. Ex-health authority regulatory experience is highly desirable. Role expectations Regulatory Strategy and Execution Develop and implement regulatory strategies for diagnostic devices including physical devices, software in medical device (SiMD) and software as a medical device (SaMD). Ensure regulatory submissions are well-organized, scientifically accurate, of high quality, and presented in a way that facilitates agency review and fulfills strategic goals. Partners with relevant internal business partners and lead the effort to solve technical and strategic challenges with broad impact on the diagnostic device portfolio, including product concept development, product architecture and technical development, study design, verification and validation strategies, etc. Articulate potential regulatory scenarios and the associated risks/mitigations and recommend a path forward in alignment with business objectives. Monitor external regulatory trends, including but not limited to the involving landscape of AI/ML initiatives to anticipate potential business/regulatory risks at the portfolio level. Communicate potential risks and lead the implementation of regulatory measures to ensure competitive advantages and success of the product portfolio. Act as RA SME in assigned area and contribute to RA department priorities with a focus on enhancing regulatory intelligence and driving regulatory strategy execution. Serve as the regulatory subject matter expert for deploying AI/ML-enabled functions across existing and planned products, and promote the use of emerging regulatory tools, such as Predetermined Change Control Plans, when appropriate to support business objectives and product lifecycle needs. As assigned by management, may support global submission activities (new product development, sustaining products, new/updated features, etc.), regulatory compliance or operation activities (recall, non-conformance, audit, process improvement, country approval, distribution control, annual update, post-market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.) External Influencing, Capability and Culture Building Influence and interact directly with Health Authorities on policy issues that support our portfolio. Build trusted relationships with industry partners and Health Authorities. Represent Align Technology in relevant external influencing venues. Lead the effort to create external regulatory positions and disseminating the positions via external influencing venues (e.g. working/trade groups, publications, presentations, etc.). Actively engaged in coaching and mentoring internal cross-functional team on regulatory strategy and risk management. Build and cultivate a strong partnership with internal business partners. What we're looking for

Education:

Bachelor's degree in engineering, regulatory affairs, quality, or related field.

Experience:

10+ years of experience in regulatory affairs, quality, device development or related field in the medical device industry. Higher education (Masters, Ph.D. etc.) can substitute for years of experience. Extensive experience with diagnostic SaMD products, AI/ML-enabled SaMD products, headless products, and US FDA regulations/guidance and global standards. Ex-health authority regulatory experience is highly desirable. Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) to influence effectively and bring about consensus on policies that support business objectives.

Skills:

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 Strong analysis, organizational, follow-up skills, as well as attention to detail. Exercises good judgement to research, analyze, evaluate, plan and solutioning, and execution to deliver results or resolve issues. Being able to drive, coordinate with stakeholders and activities to analyze issues, situation and come up solution. Familiarity with digital platforms, data analytics, and AI-driven solutions for quality and regulatory processes is highly desirable.

Communication:

Demonstrated strategic/critical thinking ability and drive for successful regulatory outcomes. Result oriented with strong initiative and accountability. Able to communicate complex ideas/issues and influence others (including senior leaders) to adopt a different point of view. Ability to work well in a matrixed, dynamic environment with flexibility and agility.

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. Travel Requirement Up to 10% international and domestic travel necessary. Pay Transparency If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate's 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. 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 Align's 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. About Align Technology Your growth and well-being: At Align, every smile matters. We're committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect: Health and well-being programs to keep you thriving in both body and mind. Employee-exclusive discounts on Invisalign products. Learning opportunities through online learning resources and support for your individual development plans. Inclusive, global workplace that fosters collaboration, recognition and belonging. Country and/or role specific details will be shared with you by your recruiter during the interview process.

Discover Align:

We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day. Align's core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives. We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration. At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time. As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation. Eager to learn how we embrace our global differences and nurture employee well-being? Explore Align's culture here! Want to discover more about exocad and Cubicure ? Click on their names for additional information.

Applicant Privacy Policy:

Review our Applicant Privacy Policy for additional information.

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. 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Sr. Manager, Regulatory Affairs