Regulatory Affairs Manager — Medical Devices (510(k))
CorDx
A multi-national biotech organization in Atlanta is seeking a Regulatory Affairs Manager to oversee regulatory documentation for medical devices. The ideal candidate will have extensive experience in regulatory affairs, knowledge of FDA regulations, and the ability to work collaboratively with various teams. A comprehensive benefits package is offered, promoting professional growth and a flexible work environment. #J-18808-Ljbffr CorDx
- ...Regulatory Affairs Manager In this critical role, you will lead regulatory strategies, product submissions, and a... ...Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.) Define and execute submission...Medical device
- ...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...Type: Full time Job Title: Senior Regulatory Affairs Manager Location: Onsite - Atlanta, or San... ...medical device products, including 510(k) and submissions. This individual will...Medical deviceFull timeFlexible hours
- ...Zywie is seeking a Principal Regulatory Affairs Specialist to play a key role in the company... ...opportunity for an experienced medical device Regulatory Affairs professional who... ...a strong track record preparing and managing 510(k) submissions, including Traditional,...Medical device
- Globalchannelmanagement is seeking a Remote Regulatory Affairs contractor with 5-10+ years of global medical device regulatory experience to lead end-to-end FDA 510(k) submissions and EU MDR readiness. You will review design controls, V&V, risk, labeling, and software...Medical deviceRemote jobContract workFor contractors
- Getinge in Atlanta, Georgia is seeking a Project Manager for Quality and Regulatory to lead Quality Management System enhancement initiatives. This... ...along with experience in project management within the medical device industry. The position allows for remote work, but...Medical deviceRemote job
- ...including more than 40 of the top 50 medical device companies and 9 of the top 10... ...of Operations, the General Manager is responsible for the... ...satisfaction, employee engagement, regulatory compliance, operational... ...Flexible Spending Accounts401(k) program with Company match that...Medical deviceFull timeWork at officeImmediate startWorldwideFlexible hours
$145k - $165k
...Position Overview The Compliance Manager is a member of the FUJIFILM Holdings America... ...elements that support FUJIFILM's Medical Device Compliance Program in line with OIG's guidance... ...colleagues in Legal, IT, HR, Finance, Regulatory and other core functions in order to...Medical deviceRemote workFlexible hours$85k - $95k
...course of lives. The Regulatory and Clinical... ...the active implantable medical devices for the Neuromodulation... ...performance periodically. Manage the overall... ...submissions assigned (510(k); IDE & IDE Supplements... ...medical device regulatory affairs or a Ph.D. with at least...Medical deviceRemote workWorldwideFlexible hours- ...rapid testing and point-of-care medical device solutions used in the... ...Job Title : Senior Production Manager Location : Alpharetta, GA... ...maintaining compliance with regulatory and safety standards. Responsibilities... ...vision insurance. ~401(k) plan with generous company...Medical deviceFlexible hours
- ...including more than 40 of the top 50 medical device companies and 9 of the top 10... ...of Operations, the General Manager is responsible for the... ...Maintains compliance with all regulatory requirements to include, but... ...Flexible Spending Accounts 401(k) program with Company match...Medical deviceFor contractorsImmediate startWorldwideFlexible hours
- ...work on high-stakes litigation involving medical devices, pharmaceuticals, and complex tort... ...What You'll Do: Support and manage products liability and related litigation... ...discretionary bonus Comprehensive benefits, including healthcare, 401(k), and PTO...Medical deviceFull time
$80.9k - $127.05k
...time 20186058 What Regulatory Affairs contributes to... ...enable pharmaceutical, medical and biotechnology companies... ...Regulatory Affairs team by managing regulatory... ...registrations, including FDA 510(k) submissions, EU Technical... ...and medical device requirements. Monitor...Medical deviceFull timeTemporary workWork experience placementLocal areaImmediate startRemote workFlexible hours- ...and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.Sotera Health goes to market through its three best-in-class businesses...Medical deviceFull timeWorldwide
- ...Alpharetta, GA, is seeking an experienced Senior Production Manager to oversee manufacturing operations. The ideal... ...offers a competitive compensation package along with comprehensive benefits like medical insurance and a generous 401(k) plan. #J-18808-Ljbffr CorDxMedical device
- Avanos Medical is seeking a Senior Software Engineer in Alpharetta... ...activities across connected medical devices. You will review external... ...with Systems, Software, QA, Regulatory, and CDMO partners. The role emphasizes requirements management, design controls, and...Medical device
$325k - $430k
...with Marketing, Market Access, Medical Affairs, and Product Development.... ...Implement CRM and pipeline management rigor.Culture & Compliance-... ...adheres to all quality and regulatory expectations.Skills and Experience... ...within the Medical Devices / Neurostimulation industry....Medical deviceFull timeRemote workWorldwide$129.59k - $155.5k
...expectations in compliance (social, regulatory, and quality), customer... ...relationships with the ECMs, managing end-to-end product supply of... ...cosmetics, OTC, pharmaceuticals, or medical device industry.Must have 4 years of... ...suite, including our 401(k) and Profit Sharing plan. The...Medical deviceFull timeContract workWork at officeRemote work- ...strategy for a newly launched product line. This senior role requires 10-15 years in sales leadership within the Medical Devices industry, with a focus on team management and commercial strategy. The ideal candidate will be responsible for building the sales organization and...Medical device
- ..., GA area to deliver on-site and remote technical service for Medical OEM instruments. You will diagnose issues, perform installations... ...work independently in a fast-paced environment while ensuring compliance with SOPs and regulatory guidelines. #J-18808-Ljbffr JobsblMedical deviceRemote job
- ...offering expertise in property management, investment management,... ...assets and over $36.5 billion of regulatory assets under management. Greystar... ...Offered*:Competitive Medical, Dental, Vision, and Disability... ...every 5 years thereafter).401(k) with Company Match up to 6%...Full timeContract workWork at officeLocal areaImmediate start
- ...Employer Industry: Medical Device Industry. Why consider this job opportunity: Opportunity for career advancement and growth within the... ...is Required (Qualifications): Minimum of 5 years of product management, upstream/inbound marketing, or product development experience...Medical deviceWork experience placement
- ...rapid testing and point-of-care medical device solutions used in the... ...in healthcare. Position: QA Manager Location: Alpharetta/Chamblee... ...quality management systems, regulatory compliance, and team leadership... ...production, and regulatory affairs teams to ensure new products...Medical device
$80k
Inspire Medical Systems, Inc. is looking for a Territory Manager in Atlanta, GA. This role involves leading commercialization activities for their Obstructive... ...least two years of sales experience in the medical device or pharmaceutical industry, or alternatively, five...Medical device- ...performance of services and maintain a demeanor complementary to medical ethicsAdjusts immobilization devices to obtain optimum views of specified area of body... ...with an employer contributionLife InsurancePTO401(k) retirement plan with a company matchAnd more!Equal Employment...Medical deviceLocal areaNight shift
$135k - $175k
Overview We have an immediate opening for a Strategic Account Manager with a leading manufacturer of regenerative medicine products... .... Qualifications 5+ years of experience in the healthcare/medical device industry. Strong track record working with IDNs, GPOs, and other...Medical deviceBase plus commissionImmediate start$130k - $175k
Regional Sales Manager Location: Remote - Candidates must reside in North Carolina, South... ...5-7+ years of progressive experience in medical device sales, healthcare sales, or a related... ...Medical, dental, and vision insurance ~401(k) with company match ~ Paid time off...Medical deviceInterim roleRemote work$120k - $160k
...planes, or optimizing advanced medical equipment and consumer... ...background, proven experience managing remote sales teams, and a track... ...construction, agriculture, medical device, or machine builder markets.Residence... ...Injury InsuranceCompany 401(k) Plan with 4% employer match (...Medical deviceRemote workFlexible hours$158.4k - $237.6k
...: CitiSeeking a Relationship Manager to join our growing Healthcare... ...includes companies in the Medical Device, Tools & Diagnostics, Life Sciences... ...compliance with regulatory requirements and Citi's policies... ...dental & vision coverage; 401(k); life, accident, and disability...Medical deviceFull time- ...biotech organization is seeking a Senior QA Manager in Atlanta, GA. The role involves... ...managing the QA team, ensuring compliance with regulatory standards, and collaborating with... ...compensation and a range of benefits, including medical insurance and flexible PTO. #J-18808-...Medical deviceFlexible hours
$102.62k - $145.93k
...manufacturing, laboratory, semi-conductor manufacturing, and medical device projects. You will provide management review and oversee our regional science and... ...vision, life insurance and supplemental benefit plans401(k) plan with a generous employer matching...Medical deviceFor contractorsWork at officeRemote workWork from homeFlexible hours
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