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... .... Job Type: Full time Job Title: Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position... ...submission of regulatory documents including 510(k), technical files, and other filings...Medical deviceFull timeFlexible hours
- Globalchannelmanagement is looking for a Remote Regulatory Affairs contractor based in Atlanta, Georgia. The successful candidate should... ...5-10 years of relevant global regulatory experience in medical devices. The role emphasizes experience with FDA 510k submissions...Medical deviceRemote jobFor contractors
- ...Description: The Director of Regulatory Affairs will be responsible for the... ...of biologics and medical device applications in addition other... ...Affairs will be responsible for managing supplier and distributor... ...License Application (BLA), 510(k), and Pre-Market Approval (...Medical deviceWork at officeAfternoon shift
$138.1k - $315.6k
...world. EY - Life Sciences Regulatory Submissions - Senior Manager National Risk -... ...biotechnology, pharmaceutical, medical device manufacturers, and the medical... ...Systems Regulatory Affairs Laboratory Information Management... ..., pension and 401(k) plans, and a wide range...Medical deviceSummer holidayFlexible hours- ...compliance and delivering confidence through effective quality management systems while collaborating across various departments.... ...and FDA standards. Benefits include competitive salary, medical plans, generous 401(k) with employer match, and paid leave. #J-18808-Ljbffr...Medical device
- ...excellent customer support. The ideal candidate must have a B.S. in a relevant engineering field and strong troubleshooting skills with medical devices. Benefits include a competitive compensation package with medical, dental, and 401(k) matching. #J-18808-Ljbffr BrainlabMedical deviceFull time
$80k
Inspiresleep is seeking a Territory Manager in Atlanta, Georgia, to lead commercialization... ...2 years of sales experience in the medical device industry, with strong computer skills. The... ...and comprehensive benefits including 401(k) matching and flexible time off. #J-1880...Medical deviceFlexible hours- 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
- A medical technology company located in Atlanta, Georgia, is seeking a Project Manager to support critical initiatives in medical device development. The role involves planning, execution, and coordination across various teams, requiring strong organizational skills and...Medical device
- Sigvaris Management AG is seeking a Clinical Sales Specialist for the Lymphedema & Lipedema Business... ...some sales experience, preferably in the medical device industry. Benefits include medical plans, life insurance, and a 401(k) match. #J-18808-Ljbffr Sigvaris Management...Medical deviceRemote job
$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- ...Job Description Remote Regulatory Affairs contractor requires: ~ Bachelor... ...~5-10 years+ of global medical device regulatory experience ~ Proven... ...stakeholders Ability to manage multiple deliverables and... ...DUTIES: ~ FDA 510(k) submission Conduct comprehensive...Medical deviceRemote jobFor contractors
$80k
...Overview Inspire is the first of its kind medical device designed to make a difference in the... ...culture by offering excellent benefits, 401(k) matching, ESPP, flexible time off (FTO)... ...Job Functions The Inspire Territory Manager will lead commercialization activities introducing...Medical deviceWork experience placementWork at officeLocal areaFlexible hoursNight shift- ...General Manager page is loaded## General Managerlocations: Atlantatime... ...more than 40 of the top 50 medical device companies and 9 of the top 10... ...compliance with all regulatory requirements to include, but... ...Flexible Spending Accounts* 401(k) program with Company match that...Medical deviceImmediate startWorldwideFlexible hours
$90k - $111k
...looking for a dynamic Strategic Account Manager to join our regional team. This person will... ...equivalent experience Prior top‑ranked medical device and/or pharmaceutical, business‑to‑... ...Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP),...Medical deviceTemporary workFlexible hoursShift work- Quality and Regulatory Specialist - Americas Location: Norcross... ...to Quality Management System (QMS) initiatives... ...submissions (e.g., FDA 510(k), NDA supplements, Health... ...Assurance and/or Regulatory Affairs within a regulated industry (medical device or pharma preferred)...Medical deviceFlexible hours
$100k - $120k
OXOS Medical, Inc. empowers every provider with... ...imaging devices that push the boundaries... ...is searching for a Regulatory Systems Specialist... ...regulatory processes and manage requirements for... ...and submit 510(k)s, Q‑submissions,... ...Sciences, Regulatory Affairs or related field....Medical device- ...together, we can continue to shape the future of the medical device industry. TERRITORY SALES MANAGER - NEUROSURGERY & ORTHOPEDIC SPINE DIVISION: Are you an... ...for advancement Medical, Dental and Life coverage 401(k) plan Monthly car allowance plus 100% gasoline reimbursement...Medical deviceBase plus commissionWork at officeNight shift
- ...Provide meaningful care with medication, TMS, and ketamine therapy—all... ...medical, dental & vision 401(k) – because your future deserves... ...ketamine infusions Prescribe and manage medications for mental health... ...Are: Using advanced medical devices recently released to market, Serenity...Medical deviceFlexible hours
$172k - $287k
...including sales, product management, and marketing, to... ...(e.g., Market Access, Regulatory, Commercial Operations,... ...Chain, International, Medical, Business Development,... ...diagnostic, and or medical device industry and hospital systems... ...-tax accounts, a 401(k) with company...Medical deviceContract workTemporary workLocal areaRemote workNight shift- ...Scholarship program for employees Matching 401(k) plan for all employees Comprehensive insurance plans for medical, dental and vision coverage for full‑time employees... ...employees Electronic medical records and mobile devices for all clinicians Incentivized bonus plan...Medical deviceFull timeReliefFlexible hours
$110k
...plus commission Benefits include: Medical, Vision, and Dental Insurance, 401(k), Stock Options NOTE: You must have... ...Inc. is a privately-held medical device company focused on innovation solutions... ...We are currently hiring Territory Managers in Atlanta. In this role, you will...Medical deviceBase plus commissionCurrently hiringLocal areaWorldwide- ...the Senior Commercial Director, Product Management and existing Sales Team and Sales Training... ...). Sales experience within the medical device and/or pharmaceutical industry preferred... ...accident, cancer and hospital confinement 401(k) with Company match (dollar for dollar 1...Medical deviceTemporary workWork experience placementCasual workWork at officeLocal areaRemote work
$60k - $100k
Biologics Account Manager (Atlanta, GA) Life Unlimited. At Smith+Nephew we design and manufacture... ...direct sales experience with 4 years in medical device industry preferred Experience selling... ...Medical, Dental, Vision coverage; 401(k); Tuition Reimbursement; generous PTO;...Medical deviceFlexible hoursNight shift$75k
...across MDT account teams, including District Managers (DM), Sales Area Directors (SAD), Sales... ...Nice to Have Previous experience with medical device/OR sales. Proven track record in sales... ...‑being program) Incentive plans 401(k) plan plus employer contribution and match...Medical deviceContract workTemporary workH1bWork at officeLocal areaRemote workFlexible hours$90k - $205k
...Territory Manager – Atlanta, GA Take the lead in transforming hospital... ...equipment in a fast-growing medical market Competitive compensation... ...benefits including 401(k) match, tuition reimbursement,... ...capital equipment or medical device sales success Skilled at navigating...Medical device$90k - $205k
Jacobs Management Group is seeking a Territory Manager in Atlanta, GA, to transform hospital and surgery center workflows by introducing advanced... ...from $90,000 to $205,000, plus comprehensive benefits including 401(k) match and PTO. #J-18808-Ljbffr Jacobs Management GroupMedical device$109.92k - $151.14k
...software products for medical devices are developed, documented... ..., and aligned with regulatory standards, while also... ...development cycles, Backlog management and user stories,... ...Assurance, Regulatory Affairs, Product Management, and... ...vision insurance, 401(k) retirement plan, life...Medical deviceTemporary workWork at officeLocal area$60k - $70k
A progressive medical device company is seeking a Regional Account Manager Associate located in Atlanta, GA. This role involves managing products and ensuring strong... ...with comprehensive benefits such as medical coverage and a 401(k) plan. #J-18808-Ljbffr Applied MedicalMedical device
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