Transforming smiles,
changing lives.
Regulatory Affairs Manager
The 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 standalone 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 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 standalone 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 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 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.
- As assignment 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.
- 6-10 years of experience in regulatory affairs, quality, device development or related field in the medical device industry. Higher education (master, Ph.D. etc.) can substitute for years of experience.
- Extensive experience with diagnostic SaMD 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.
- 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.
- Proficiency in Microsoft Office applications
- Ability to travel domestically and internationally, up to 10%
Complementary Skills
Communication:
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 matrix, 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.
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.
Align Technologyについて
Your growth and well-being:
At Align, every smile matters. We are committed to supporting your health, contentment, and professional development through tools and initiatives designed to help you thrive. While benefits may vary by location, you can expect the following wherever you join us:
At Align, every smile matters. We are committed to supporting your health, contentment, and professional development through tools and initiatives designed to help you thrive. While benefits may vary by location, you can expect the following wherever you join us:
- Health and well-being programs to keep you thriving in both body and mind.
- Employee discounts on Invisalign products.
- Learning opportunities though online learning resources and support for your individual development plans.
- Inclusive workspace that fosters diversity and collaboration.
Country-specific details will be shared with you by your recruiter during the interview process.
Discover Align:
At Align Technology, 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.
Discover Align:
At Align Technology, 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.
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.
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 diversity and nurture employee well-being?
Applicant Privacy Policy:
Review our Applicant Privacy Policy for additional information.
Global Diversity Statement:
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.
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.
Review our Applicant Privacy Policy for additional information.
Global Diversity Statement:
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.
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.
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