Senior Regulatory Affairs

Description

About this opportunity

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners

Key Responsibilities

In this role, you will…
Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.
Perform coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Coordinate and implement MDR requirements related efforts in the organization
Assess product changes and their global regulatory impact.
Lead or compile all materials required in submissions, license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes
Coordinate project submission timelines in multiple regions

Skills, Knowledge & Expertise

In this role, you’ll need …

BA or B.Sc. degree is required.
A degree in engineering, materials, chemical sciences is preferred.
10 years relevant/regulated industry experience
Demonstrated ability to communicate regulatory requirements clearly, accurately, and concisely
MDR knowledge and preferably experience in implementing it
Ability to confront new Regulation/ Guidance document
Experience with previous 510(k) submissions
Experience with previous technical file dossiers
Expertise in product development and its application in global regulatory strategy

About Align Technology
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:
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.

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?
Explore Align's culture here!
Want to discover more about exocad and Cubicure? Click on their names for additional information.

Applicant Privacy Policies:

Review our Applicant Privacy Policies 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.