Regulatory Strategy Associate, Ophthalmic Devices
IPS Vantage Tech Services Pvt. Limited
IPS Vantage Tech Services Pvt. Limited in Lake Forest, CA seeks an Regulatory Affairs Strategy Associate to drive regulatory strategy, ensure local product registration, and facilitate health approvals for ophthalmic products. You will coordinate regulatory activities with plants, agents, and authorities, support medical device and pharmaceutical families, and ensure GMP/GxP compliance through SOPs. Bachelor’s degree with related experience required and strong documentation skills expected. #J-18808-Ljbffr IPS Vantage Tech Services Pvt. Limited
- ...brilliantly. With more than 25,000 associates, we innovate fearlessly,... ...is part of Alcon's Quality & Regulatory Affairs function, a team that... ..., Regulatory Affairs Strategy (Professional Path) , reporting... ...competitive advantageSupport medical device and/or pharmaceutical...SuggestedHourly payFull timeTemporary workLocal areaRelocation packageFlexible hours
- Alcon is seeking a Manager I in Regulatory Affairs Strategy to coordinate compliance activities and lead projects in Lake Forest, California. This role involves collaboration with various stakeholders to secure product approvals and drive regulatory strategies. The ideal...Suggested
- ...development and implementation of US and Canada regulatory strategic and tactical planning (RSTP)... ...requirements. Assures that regulatory strategies defined within the Global Regulatory... ...affiliate regulatory strategies (US or Canada device or combination product (device primary)...SuggestedFull timeLocal area
- ...Alcon is seeking a Director of R&D Quality Assurance to lead quality governance for surgical ophthalmic devices. The role involves strategic quality reviews, regulatory compliance, and collaboration across R&D, Regulatory Affairs, and Operations. Applicants should have...Suggested
- ...brilliantly. With more than 25,000 associates, we innovate fearlessly,... ...is part of Alcon's Quality & Regulatory Affairs function, a team that... ...Manager, Regulatory Affairs Strategy (Professional Path), reporting... ...products in the medical device and/or pharmaceutical families...SuggestedHourly payFull timeTemporary workLocal areaRelocation packageFlexible hours
- ...Technology is hiring a Senior Specialist for Regulatory Affairs in Irvine, CA with a strong... ...requires substantial experience in medical device regulations, ensuring compliance with... ...development of submissions and ongoing regulatory strategy. #J-18808-Ljbffr Jenavalve Technology
$68k - $136k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...results for millions of people. The Regulatory Affairs Specialist II is responsible... ...plans. Implements Division Regulatory Strategy in specific product related activities....Full timeWork experience placementWorldwideShift work- ...Job Description Job Description Description: JOB PURPOSE: · Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. · Serve as regulatory lead for novel oncology diagnostic technologies...
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...Medical is a new-generation medical device company with a proven business... ...Description Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future... ...Contribute to regulatory strategy development and regulatory submissions...Local area- Please find below the JD for the role of Regulatory Affairs Strategy Associate at Lake Forest, CA. Regulatory Affairs Strategy Associate The Regulatory... ...and approvals. Support products in the medical device and/or pharmaceutical families, ensuring adherence to all...Local area
- Applied Medical is seeking an Associate Specialist in Premarket Regulatory Affairs to join our on-site team in California. You will support regulatory strategy, global submissions, and QMS compliance while collaborating with cross-functional teams to ensure products meet...
$225k - $250k
...advancing innovative long-term ophthalmic drug delivery technologies... ..., and medical devices. Our scientists, engineers,... ...Medical Affairs, Commercial, and Regulatory teams to support external scientific... ...education, patient identification strategies, and OD referral initiatives...Full timeWork at officeRemote work$235k - $265k
...Role The Senior Director, Global Regulatory Lead (GRL) — Devices & Regenerative Aesthetics will serve... ...execute integrated global regulatory strategies across the full product lifecycle —... ...regulatory opportunities and risks associated with potential assets and convert findings...- ...brilliantly. With more than 25,000 associates, we innovate fearlessly,... ...is part of Alcon's Quality & Regulatory Affairs function, a team that... ...I, Regulatory Affairs Strategy (Professional Path) ), reporting... ...competitive advantageSupport medical device and pharmaceutical products,...Hourly payFull timeTemporary workLocal areaRelocation packageFlexible hours
- ...within Aesthetics Medicine and serve as a key partner to the Asset Strategy Leader (ASL), asset strategy planner, and deliverable team... ...includes supporting the development and launch of novel medical device products, new clinical indications, and the global expansion of...Full timeLocal area
$122k - $212.75k
...healthcare compliance principles into business strategies, operations, and decision-making... ...potential concerns.Monitor changes in the regulatory and healthcare compliance environment... ...standardsExperience within the medical device, pharmaceutical, biotechnology, or broader...Full timeLocal areaImmediate start- ...Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project... ...regulatory requirements for non-medical devices, and medical devices. Assess the... ...technical regulatory skills to propose strategies on complex issues. Ensure compliance with...
$95.8k - $159.6k
...Flexibility: Hybrid or OnsiteSenior International Regulatory Affairs SpecialistIrvine, CAJoin a team... ...this role, you will support regulatory strategy, submissions, and product lifecycle... ....Experience working with medical devices or other regulated healthcare products.$...Full timeFor contractorsLocal area$92k - $148.35k
...and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory... .... Responsible for developing regulatory strategies, ensuring compliance, and supporting... ...experience with Class II or Class III Medical Devices strongly preferred.Experience...Full timeContract workTemporary workLocal areaImmediate startFlexible hours3 days per week- Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables. Prepare... ...and experience with Medical Device Single Audit Program (MDSAP) and EU/UK...Immediate start
- ...Dental. We are seeking an experienced Regulatory Affairs Specialist to support global regulatory... ...ideas for developing and implementing strategies and processes. Reviews and approves... ...files. Maintains company registrations and device listings in the US, Canada, and other...
$110.1k - $183.4k
...Flexibility: Hybrid or OnsiteStaff International Regulatory Affairs SpecialistIrvine, CAIn this... ...local, regional, and global regulatory strategies.Advise cross-functional teams on... ...regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or...Full timeFor contractorsLocal area- ...RxSight, a California-based ophthalmic medical technology company in Aliso Viejo, is seeking a Quality Systems Specialist – Equipment Management. The role owns the equipment lifecycle from intake to retirement and ensures calibration/PM scheduling and event tracking across...
- ...Learfield in Irvine, CA, seeks a Director of Commercial Finance to act as a financial partner for Paciolan, driving pricing strategy, client-level economic modeling, commission design, and long-range planning to ensure margin and revenue growth. You will own pricing...
- ...YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development... ...supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution...Full timeLocal area
- ..., Glaukos Corporation is an ophthalmic pharmaceutical and medical technology... ...studies supporting medical device development. This role leads... ...in compliance with regulatory requirements, delivered on time... ...and implement mitigation strategies.• Oversee clinical data quality...Local areaRelocation package
- Job-ID31554631Reference25-04530 Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities...Work at office
$89.2k
...enthusiastic individual for a Senior Regulatory Affairs Specialist position... ...growing active implantable device portfolio. This role will be... ...as developing regulatory strategies. The role requires strong US... ...filings, and supports associated global submissions as needed...Hourly payWork at officeLocal areaRelocationShift work3 days per week- ...Scientific is partnered with an established medical device innovator developing life-changing technologies... ...expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and global compliance activities...
- The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique... ...and PMAs—for Class III cardiovascular medical devices. In this highly visible role, you’ll shape regulatory strategy, influence design and development decisions,...Full timeContract workRemote work3 days per week
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