1,097 Results for

Technology Jobs in Swampscott, MA

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Director, Regulatory Affairs - Advertising, Promotional And Labeling #4810 Grail

Sunnyvale, CA

$189,000–$271,000 / year

The Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges.

30+ days ago

Principal Regulatory Affairs Strategist Intuitive Surgical Inc

Sunnyvale, CA

The Principal Regulatory Affairs Strategist works upstream with R&D, Clinical Affairs, Quality, Product, and business stakeholders to shape intended use, indications, claims, classification, evidence needs, regulatory pathway, and global market access strategy before submission plans are fully defined. The strategist develops practical US and OUS regulatory options for programs, guides clinical evidence strategy, and helps senior leaders understand the risks, trade-offs, and decisions needed to move technologies toward market authorization.

30+ days ago

Senior Regulatory Affairs Specialist Pacer Group

Pacheco, CA

$50–$55
Quick Apply

Non Negotiable requirements -EU IVDR and or IVDR experience needed Position Summary We are seeking an experienced and detail-oriented Senior Regulatory Affairs Specialist to support global regulatory compliance and market access activities for our In Vitro Diagnostics (IVD) product portfolio. Regulatory Compliance Maintain technical documentation including Technical Files, General Safety and Performance Requirements (GSPR), Clinical Evaluation Reports (CER), risk management files, and supporting regulatory records.

10 days ago

Associate Director Regulatory Affairs Advertising & Promotion - Oncology AbbVie Inc

South San Francisco, CA

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

13 days ago

Vice President, Regulatory Affairs Insitro

South San Francisco, CA

$313,000–$333,000 / year

Reporting directly to the Chief Medical Officer, you will develop and implement global regulatory strategies supporting multiple therapeutics - small molecules, biologics, and oligonucleotides - and diagnostics across our three therapeutic areas: neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology. You will be at the forefront of implementing and influencing new regulatory policy across multiple jurisdictions using objective, data-driven approaches, treating health authorities as key partners who share our vision of bringing better, more targeted drugs to patients faster.

30+ days ago

Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) Nurix Therapeutics, Inc.

Brisbane, CA

$187,800–$208,600 / year

Author, review, and compile high-quality CMC (Module 3 / Quality) content for regulatory submissions, including IND/IMPD and equivalent global filings, amendments, annual reports, and responses to health authority questions. You'll combine hands-on authoring of Module 3 (Quality) content with real strategic influence as the CMC regulatory voice on cross-functional teams, with room at the Associate Director level to own strategy and mentor junior regulatory staff.

8 days ago

Sr. Regulatory Affairs Specialist Varian Medical Systems Inc

$115,980–$159,478 / year

It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". Under the direction of Regulatory Affairs Management, this role independently leads regulatory assessments, develops strategy options, recommends compliant pathways, and advises leadership on regulatory risks, pathway options, and recommended approaches to support informed decision-making.

29 days ago

Senior Regulatory Affairs Specialist Varian Medical Systems Inc

$115,980–$159,478 / year

29 days ago

Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998 Ascendis Pharma

Palo Alto, CA

$200,000–$240,000 / year
Quick Apply

Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs?

26 days ago

Director, Regulatory Affairs Nova Pneuma, Inc.

Fremont, CA

Part time

Manage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.

8 days ago

Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810 GRAIL

Sunnyvale, CA

$189,000–$271,000 / year

30+ days ago

Associate Director, Regulatory Affairs (on-site) Abbott

Alameda, California

$148,700–$297,300 / year

The individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

30+ days ago

Associate Director, Regulatory Affairs (on-site) Abbott Laboratories

Alameda, CA

$148,700–$297,300 / year

30+ days ago

Senior Director, Regulatory Affairs Orca Bio

Menlo Park, CA

Essential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the C-Suite, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements — with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.

30+ days ago

Senior Director, Regulatory Affairs Lead Orca Biosystems Inc

Menlo Park, CA

$250,000–$300,000 / year

Essential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the CMO, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements - with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.

30+ days ago

Senior Program Director, Commercial Regulatory Affairs Compass Consulting

South San Francisco, CA

Quick Apply

Program Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.

19 days ago

Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar Consulting

South San Francisco, California

Remote

$120–$127 / hour

You will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program Director, Commercial Regulatory Affairs ".

30+ days ago

VP Quality & Regulatory Affairs Nova Pneuma Inc

Fremont, CA

Provide executive oversight of Quality Assurance activities, including but not limited to: Quality Systems, Document Control, Training, Change Control, Deviations, CAPA (including timely implementation and closure), Audits (internal, external and supplier), Risk Management, and Product Release. As a member of the executive leadership team, the VP, Quality & Regulatory Affairs fosters a culture of quality, continuous improvement, operational excellence, patient focus, accountability, and cross-functional collaboration to support the companys strategic objectives.

30+ days ago

Executive Director, Regulatory Affairs Ardelyx Inc

San Francisco, CA

$282,000–$344,000 / year

Partner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications. Qualifications: Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12-15 years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience.

4 days ago

Counsel, Global Regulatory Affairs Visa Inc

San Francisco, CA

$203,800–$326,100 / year

The Counsel must have excellent judgment and strong analytical, problem solving and client counselling skills; exceptionally strong communication skills (written and verbal); demonstrate strong attention to detail and resourcefulness; be self-motivated, entrepreneurial and a self-starter; be comfortable with using emerging technologies and Artificial Intelligence tools to create innovative and efficient ways to work; be a confident, creative, forward-thinking, and collaborative team player; and be skilled at managing multiple priorities in a fast-paced, time-sensitive, and challenging, but highly rewarding, environment. The Associate Counsel will join a dynamic legal team, and work closely with experienced lawyers across the globe and different practice groups to support and advise internal Visa teams, develop the company's thought leadership and strategy in key regulatory areas, and draft regulatory submissions and responses to government requests and public consultations.

30+ days ago

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Technology Jobs in Swampscott, MA

Director, Regulatory Affairs - Advertising, Promotional And Labeling #4810 Grail

Principal Regulatory Affairs Strategist Intuitive Surgical Inc

Senior Regulatory Affairs Specialist Pacer Group

Associate Director Regulatory Affairs Advertising & Promotion - Oncology AbbVie Inc

Vice President, Regulatory Affairs Insitro

Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) Nurix Therapeutics, Inc.

Sr. Regulatory Affairs Specialist Varian Medical Systems Inc

Senior Regulatory Affairs Specialist Varian Medical Systems Inc

Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998 Ascendis Pharma

Director, Regulatory Affairs Nova Pneuma, Inc.

Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810 GRAIL

Associate Director, Regulatory Affairs (on-site) Abbott

Associate Director, Regulatory Affairs (on-site) Abbott Laboratories

Senior Director, Regulatory Affairs Orca Bio

Senior Director, Regulatory Affairs Lead Orca Biosystems Inc

Senior Program Director, Commercial Regulatory Affairs Compass Consulting

Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar Consulting

VP Quality & Regulatory Affairs Nova Pneuma Inc

Executive Director, Regulatory Affairs Ardelyx Inc

Counsel, Global Regulatory Affairs Visa Inc

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