Senior Regulatory Affairs jobs
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SENIOR REGULATORY AFFAIRS SPECIALIST (ROBOTICS & DIGITAL SOLUTIONS) - ETHICON, INC.
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| Company | Johnson & Johnson |
|---|---|
| Address | Santa Clara, CA |
| Category | Sales/marketing |
| Date Posted | 2 days ago See detail |
Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.
Johnson & Johnson
Santa Clara, CA
...
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Senior Regulatory Affairs Specialist
Iconma, Llc
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
2 weeks ago seen See more...
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Senior Regulatory Affairs Specialist
Axelon
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
2 weeks ago seen See more...
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Senior Regulatory Affairs Specialist
Collabera
Saint Paul, MN
Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - suppliers should use: Plan and prepare documents for EU MDR Technical File original submiss...
2 weeks ago seen See more...
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VP/Senior VP, Regulatory Affairs
Biospace
San Diego, CA
Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...
3 weeks ago seen See more...
- View all Biospace jobs - jobs in San Diego, CA
Senior Regulatory Affairs, Study Start Up Specialist
Cti Clinical Trial Services Inc
Covington, KY
$73K - $92.5K a year
Perform/ oversee compliance assessments against Food and Drug Administration (FDA) lists and documents any FDA activity discovered; notifies Study Manager of any FDA activity documented per CTI SOPs. Compile/ oversee site Regulato...
3 weeks ago seen See more...
Senior Regulatory Affairs Advisor
Cook Device Solutions
Remote
$100,000 - $125,000 a year
Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...
4 weeks ago seen See more...
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Senior Manager, Regulatory Affairs - Proliant Health & Biologicals
Lauridsen Group, Inc.
Ankeny, IA
Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...
3 days ago seen See more...
- View all Lauridsen Group, Inc. jobs - jobs in Ankeny, IA
Senior Associate of Regulatory Affairs, CMC
Meitheal Pharmaceuticals Inc
Chicago, IL
Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...
3 days ago seen See more...
Senior Manager Regional Regulatory Affairs
Biospace
King Of Prussia, PA
You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...
4 days ago seen See more...
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Manager/Senior Manager-Regulatory Affairs-West
Invenergy
Denver, CO
$122K - $155K a year
Collaborate with the other Regulatory Affairs team members in other regions and manage other staff members as appropriate. Manage external counsel and consultants. Build personal relationships with external stakeholders managing r...
a month ago seen See more...
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Senior Regulatory Affairs Specialist
Collabera
Temecula, CA
Must have 1-3 years of experiences in Medical Device Regulatory Affairs. Skills: Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submiss...
a month ago seen See more...
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Senior Regulatory Affairs Program Lead (Biosurgery) - Ethicon, Inc.
J&J Family Of Companies
Boise, ID
Lead the overall strategy development, implementation, and coordination of Regulatory Affairs activities for medium to high-risk medical devices with minimal guidance. Ensure alignment of regulatory strategy to business strategy a...
a month ago seen See more...
- View all J&J Family Of Companies jobs - jobs in Boise, ID
CAREER OPPORTUNITY FOR YOU! Senior Regulatory Affairs Specialist
Techlink Systems
Temecula, CA
Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in. Have working knowledge in US and EU medical device submissions. Have experience supporting internal and external inspections Work cross-f...
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Senior Regulatory Affairs Specialist (LC 6103)
Techdata Service Company Llc
Irvine, CA
Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory...
a month ago seen See more...
Senior Regulatory Affairs Specialist
Pulmonx Corporation
Redwood City, CA
Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Advises stakeholders of regulatory requirements for quality, preclinical and clinical data to meet applicable regulat...
a month ago seen See more...
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Senior Regulatory Affairs Specialist
Ultimate Staffing Services
Irvine, CA
Regulatory affairs experience with Class II and III medical devices. Outside of the US experience is preferred on top of domestic experience, specifically the EU.. Proven track record of developing written RA plans & strategies.....
a month ago seen See more...
Manager/Senior Manager-Regulatory Affairs-West
Invenergy Llc
Portland, OR
Collaborate with the other Regulatory Affairs team members in other regions and manage other staff members as appropriate. Manage external counsel and consultants. Build personal relationships with external stakeholders managing r...
a month ago seen See more...
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Senior Regulatory Affairs Specialist
Eastridge
Irvine, CA
Manage and coordinate international product registration submissions, ensuring compliance with regulations and standards. Lead regulatory efforts for global product registrations to support business growth and geographical expansi...
2 months ago seen See more...
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Regulatory Affairs Senior Program Manager
Biospace
San Francisco, CA
6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...
6 days ago seen See more...
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Senior Director, Global Medical Affairs Strategy - Solid Tumors New
Genmab A/S
Princeton, NJ
Develop and execute the overall Medical Affairs Strategy for designated product in NSCLC therapeutic area. Serve on Compound Development Team as Global Medical Affairs representative; Co-Lead Global Commercialization Team. Serve a...
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Senior Associate, Regulatory Oversight Management New
Bny Mellon
Pittsburgh, PA
Communicates with internal and external parties as needed and makes recommendations on necessary procedural/control changes on Regulatory Oversight Management matters. Gathers data and prepares materials for more senior team membe...
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Regulatory Affairs Senior Consultant
Medenvoy Global Bv
Remote
From $100,000 a year
Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...
2 weeks ago seen See more...
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Senior Manager, Regulatory Affairs Biocides - Remote
Steris
Alpharetta, GA
Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...
2 weeks ago seen See more...
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Head/ Sr Director of Global Regulatory Affairs New
Predicine, Inc
Hayward, CA
Responsible for setting strategy and leading the Predicine Global Regulatory Affairs organization. Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnos...
6 hours ago seen See more...
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Director Regulatory Affairs New
Nikang Therapeutics Inc
Wilmington, DE
Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...
6 hours ago seen See more...
Manager - Regulatory Affairs - Therapeutic Area New
Biospace
Plainsboro, NJ
Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...
10 hours ago seen See more...
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Senior Regulatory Operations Specialist – Digital Health Technologies (on-site) New
Abbott
Alameda, CA
Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO. An excellent retirement savings plan with high employer co...
12 hours ago seen See more...
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