Regulatory Affairs Manager
Katalyst Healthcares and Life Sciences
Responsibilities:
Requirements:
- The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
- Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
- Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
- Document regulatory strategies for product submissions.
- Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
- Facilitate FDA pre-submission meetings
- Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
- Support EU representatives in their creation of CE/IVD Technical Files
- Support global regulatory registration representatives for product registration activities
- Perform regulatory assessment of new and changed products.
- Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment.
- Participate in business meetings with potential new external partners.
- ssist the Regulatory department in updating, improving, and crafting internal policies and procedures.
Requirements:
- B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science at least 5 years of IVD Regulatory Affairs experience.
- Hands-on experience with 510(k), PMA, and PMA supplement submissions.
- Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
- bility to lead multiple projects and meet deadlines.
- Strong communication and teamwork skills.
- Capacity to communicate regulations to technical functions within the company.
- Experience as the RA representative on project core teams.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Manager in Charlotte, NC vacancy
- Job Description Job Description Lead the Way in Clinical Excellence – Join Connected Crew as Our Chief Clinical Officer (CCO) Are you ready to make a meaningful impact in the healthcare industry? At Connected Crew, located in Charlotte, NC, we’re dedicated to delivering...Suggested
Connected Crew
Charlotte, NC4 days ago - ...Dental Solutions team. This role develops regulatory strategies for existing, new, and... ...and other (regulated) products. This role manages and submits 510ks for the products and manages... ...activities for less senior Regulatory Affairs professionals, including but not limited...SuggestedWork at officeRemote workWorldwide
Dentsply Sirona
Charlotte, NC1 day ago $80k - $90k
...Job Description Job Description Salary: $80,000-$90,000 Manager of Contract Administration and Compliance Job Overview The Manager of Contract Administration and Compliance serves as an independent control point for contract compliance, document discipline...SuggestedFull timeContract workFor contractorsFor subcontractorCasual workWork at officeRelocationMonday to FridayRed Cedar Construction Services, LLC
Charlotte, NC11 days ago- ...providing a white-glove experience for clients. Industry Management Consulting Type Privately Held About the Role The... ...programs, conducting risk assessments, and providing guidance on regulatory requirements. The role is highly collaborative, involving...SuggestedRemote work
- ...overseeing the implementation of the U.S. compliance regime, managing the compliance technology suite, maintaining annual corporate... ..., and ensuring that all products and services comply with the regulatory landscape. Applicants for the Chief Compliance Officer position...Suggested
- ...Head of Regulatory Affairs About the Company Top biotechnology (BioTech) company developing innovative treatments Industry Biotechnology Type Privately Held About the Role The Company is seeking a Head of Regulatory Affairs to provide strategic...
- ...Head of Policy and Regulatory Affairs About the Company Innovative layer 1 blockchain technology company Industry Information Technology and Services Type Privately Held About the Role The Company is seeking a Head of Policy to play a pivotal role...
$125k - $145k
...Construction Services is growing fast — and we’re adding a Compliance Manager to keep our multi‑state operations legally sound and audit‑... ...on legal compliance, contract review, and state‑level regulatory requirements. You’ll operate at the intersection of legal,...Contract workWork at officeLocal areaRemote workModern Construction Services
Charlotte, NC23 days ago- ...Job Description Job Description The Compliance Manager at Covenant Case Management Services is responsible for overseeing regulatory compliance, quality assurance, documentation integrity, and internal systems in alignment with NC Medicaid, DHHS, MCO requirements,...For contractorsWork at officeLocal areaRemote work
Covenant Case Management Services
Charlotte, NC10 days ago - ...tasked with designing and executing a scalable go-to-market strategy that encompasses business development, marketing, and account management functions. This role is pivotal in defining ideal customer profiles, segmenting target markets, and establishing territory...
- ...responsibilities include serving as the senior legal leader, designing and maturing an enterprise compliance program, translating legal and regulatory requirements into operational guidance, and leading the legal and compliance function with a focus on scaling and development....
- ...market share, and ensuring that all organizational activities are in line with strategic commercial goals. This role involves direct management of commercial revenue planning, maintaining global systems and procedures, and overseeing commercial reporting and dashboards....
$120k - $150k
...now or potentially in the future.) Title: Compliance Senior Manager Industry: Wholesale Insurance Brokerage Type of role:... ...functional leaders, the Compliance Consultant identifies and assesses regulatory risk, recommends practical solutions, and helps drive...Work experience placementWork at officeRyan Consulting Group, LLC
Charlotte, NC2 days ago- ...to regulations, conduct audits, and develop monitoring processes. Candidates should have at least 1 year of experience in program management or compliance, possess strong analytical skills, and be able to communicate findings effectively. This role offers the chance to...
- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology... ...activities. This includes global regulatory strategy, managing health authority interactions, and ensuring that the development...
- ...offices in Colorado, Florida, and Washington DC, Fairstead owns and manages a portfolio of more than 30,000 apartments, including pipeline... ...completeness, and program eligibility prior to submission to regulatory agencies. Establish a standardized review process and...Work at officeLocal areaFlexible hours
Fairstead ESC LLC
Charlotte, NC8 days ago - ...offices in Colorado, Florida, and Washington DC, Fairstead owns and manages a portfolio of more than 30,000 apartments, including pipeline... ...Specialist ensures compliance with all agencies, funding, and regulatory agreements. They help tenants, across multiple Fairstead...Interim roleFlexible hours
Fairstead ESC LLC
Charlotte, NC8 days ago - ...them with exceptional professionals for this role. The Compliance Manager leads a team of crew members who examine business processes, products, and services to ensure compliance with Vanguard’s regulatory obligations. The ideal candidate will have experience and...Work experience placement
- ...and leaders in engineering, R&D, product management and business development areas at our... ...for the following role: The Manager, Regulatory & Strategic Programs, under the direction... ...The role works closely with Regulatory Affairs, Engineering, Project Management, Finance...Permanent employmentImmediate startWork visa
Terrestrial Energy
Charlotte, NC23 days ago - ...development. Summary The Corporate Compliance Manager is a key member of Indicor’s Legal... ...that Indicor meets its corporate regulatory obligations while supporting business units... ...relevant experience in compliance, regulatory affairs, legal operations, HR compliance, or...Worldwide
- CAPTRUST is seeking a Compliance Manager to join our Compliance Team. The Compliance Manager will be responsible for a variety of important... ..., not only required by regulation, but also to assist in the regulatory risk mitigation. The ideal candidate has a strong, working...Temporary workLocal areaFlexible hours
- ...POSITION SUMMARY The Compliance Sr. Manager serves as a trusted compliance partner to CRC Group business units, helping design,... ...functional leaders, the Compliance Consultant identifies and assesses regulatory risk, recommends practical solutions, and helps drive...Full timeWork experience placementWork at office
CRC Group
Charlotte, NC19 hours ago - ...and style guide Assist with quality assurance tracking and follow-up to ensure deadlines and metrics are met Support staff, managers, and executives as needed to meet internal and external client needs Serve as client contact (i.e., communication to clients regarding...Work at office
PYA P C
Charlotte, NC17 days ago $117.39k
...adherence to operational KPIs from directs and vendor partners or overall performance and the quality. Coordinate with senior management and provide insights for process improvement. Communicate effectively with your team to drive individual and group performance...Local areaCoinbase
Charlotte, NC1 day ago- ...services organization seeks a General Counsel to lead its legal and regulatory functions. This role involves ensuring compliance across... ...regulatory frameworks, providing strategic legal advice, and managing corporate governance. The ideal applicant holds a Juris Doctor...
The Forge Companies
Charlotte, NC3 days ago - ...candidate will be responsible for drafting, reviewing, and negotiating various agreements, offering pragmatic risk assessments, and managing the U.S. legal and compliance framework in alignment with global standards. Executive partnership is a key aspect of the role,...
- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology Type Public Company About the Role The Company is seeking a Head of Global Regulatory Advertising and Promotion...
$80k - $120k
...regulations and other applicable federal laws. Adhere to audit protocol to ensure accuracy of documentation. Document Production/Management: Adhere to document production timelines to ensure efficiency and timely document production. Organize and maintain plan...Temporary workWork at officeLocal areaVisa sponsorshipWork visaFlexible hours- ...Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail... ..., Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic...Worldwide
$100k - $120k
...Maersk Customs Brokerage Operations Manager Maersk is a global leader in integrated logistics and have been industry pioneers for... ...impact customs brokerage operations across multiple industries and regulatory frameworks Opportunities to lead scalable training programs...Full timeRelocation package
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Manager. Be the first to apply!
Related searches
- quality regulatory manager Charlotte, NC
- regulatory affairs director Charlotte, NC
- regulatory manager Charlotte, NC
- head compliance Charlotte, NC
- director global regulatory affairs Charlotte, NC
- compliance manager Charlotte, NC
- manager regulatory affairs Charlotte, NC
- compliance director Charlotte, NC
- senior director regulatory affairs Charlotte, NC
- regulatory reporting manager Charlotte, NC