Senior Regulatory Affairs

1 week ago

Petah Tikva Center District, Israel Align Technology Full time $90,000 - $120,000 per year

Department:
Quality

Location:
EMEA-Israel

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

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. 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.

  • Regulatory Affairs Manager

    1 week ago

    Petah Tikva, Center District, Israel Medomie Full time $90,000 - $120,000 per year

    Regulatory Affairs Manager (Appointed Pharmacist not a mandatory)In this role, you will take ownership of regulatory submissions and approvals in Israel, managing the end-to-end registration process for innovative medicines, generics, and established molecules. You will serve as the key contact with the Ministry of Health and other regulatory bodies, while...

  • Regulatory Affairs Specialist

    1 week ago

    Yoqneam Illit, North District, Israel Medtronic Full time $90,000 - $120,000 per year

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeIf you have experience in regulatory compliance and enjoy working with cutting-edge medical...

  • Regulatory Affairs Specialist

    6 days ago

    Yoqneam Illit, North District, Israel Radix Engineering Full time $104,000 - $130,878 per year

    Regulatory Affairs Specialist – Medical DevicesLocation:Yokneam Illit | Full-Time PositionA global medical device company is seeking a talented Regulatory Affairs Specialist to join its team and take part in managing regulatory processes for cutting-edge medical device solutions across international markets.Key Responsibilities:Manage product registration...

  • Corporate Affairs Manager

    1 week ago

    Petah Tikva, Center District, Israel Medison Pharma Full time $90,000 - $120,000 per year

    Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to...

  • Regulatory Affairs Manager

    1 week ago

    Petah Tikva, Center District, Israel Medomie Full time ₪104,000 - ₪130,878 per year

    In this role, you will take ownership of regulatory submissions and approvals in Israel, managing the end-to-end registration process for innovative medicines, generics, and established molecules. You will serve as the key contact with the Ministry of Health and other regulatory bodies, while working closely with internal teams to drive projects forward.What...

  • Medical Affairs Manager

    5 days ago

    Petah Tikva, Center District, Israel Medison Pharma Full time $70,000 - $120,000 per year

    Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to...

  • Medical Affairs Senior Manager

    1 week ago

    Yokneam, Haifa District, Israel Johnson & Johnson Innovative Medicine Full time $90,000 - $120,000 per year

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Medical Affairs Manager Cardiovascular

    6 days ago

    Petah Tikva, Central District, Israel Medison Pharma Full time $70,000 - $120,000 per year

    Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy...

  • Medical and Scientific Affairs Senior Scientist

    1 week ago

    Petah Tikva, Center District, Israel Haleon Full time $90,000 - $120,000 per year

    Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep...

  • Research Compliance Senior Analyst

    1 week ago

    Petah Tikva, Central District, Israel The Ohio State University Full time $80,000 - $120,000 per year

    Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr- If you have questions while submitting an application, please review these frequently asked questions.Current Employees and Students:If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use...