Top Regulatory Affairs Executive jobs in Salem, NH
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive jobs
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if approved by the Company
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices. You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period. Through your engagement in this role, you will help shape the life-saving field of heart recovery. The ideal candidate will:
Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices
Be energized by joining a world-class company and regulatory team
Enjoy teamwork and thrive as a member of dynamic cross-functional teams
Build and maintain strong interpersonal relationships within and outside of the company
Adaptable and thrive in a dynamic work environment where variety is the routine.
Embrace change, continuous learning, and work skills improvement Key Responsibilities:
Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA
Provide ongoing support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations
Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance
Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings
Develop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions
Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies
Assist in the maintenance and improvement of regulatory SOPs
Interact and negotiate with regulatory agencies on defined matters as needed Qualifications
Education
Degree in engineering or science required
Advanced degree is preferred
Required
Minimum of 4 years with a Bachelor's degree or Minimum of 3 years with an advanced degree
Regulatory affairs experience in the medical device industry with a track record of successful submissions
Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance
History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred)
Experience supporting software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc)
Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304
Ability to effectively manage multiple projects and priorities
Strong communication and regulatory writing skills
Strong problem solving skills, interpersonal skills and effective team member
Results oriented. Ability to drive to completion in adherence to aggressive project schedules Preferred
Ability to comprehend principles of engineering, physiology and medical device use. Cardiovascular device experience
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) Other
Travel up to 10%
Must be able to effectively work remotely
This job posting is anticipated to close on 3.20.2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. The Company maintains highly competitive, performance-based compensation programs. . Additional information can be found through the link below. For additional general information on company benefits, please go to:
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Our Mission RQMIS’ mission is to bring about safe and effective medical devices and biotechnology products by assisting companies in navigating the regulatory process and addressing governmental requi...
Job Summary The Manager, Regulatory Affairs is responsible for defining and implementing regulatory strategies and submissions in support of new and existing market authorizations. Participate on cros...
The Director of Regulatory & Quality Affairs will be a critical team member supporting MDC's regulatory and quality affairs business and support client RA/QA strategy and regulatory submissions. The p...
Position Overview The Executive Assistant for Student Affairs is responsible for assisting the Associate Vice President/Dean in the execution of his/her duties and responsibilities. The Executive Assi...
JOB DESCRIPTION:The Platforms and Regulatory Compliance group offers best-in-class technology and incorporate industry best practices to manage risk, comply with regulations and provide assistance to ...
Salem is a town in Rockingham County, New Hampshire, United States. The population was 28,776 at the 2010 census. Being located on Interstate 93 as the first town in New Hampshire, which lacks any state sales tax, Salem has grown into a commercial hub, anchored by the Mall at Rockingham Park. Other major sites include the Canobie Lake Park, a large amusement park, and America's Stonehenge, a stone structure of disputed origins. It is the former home of Rockingham Park, a horse racetrack. The Sununu political family hails from Salem, including former New Hampshire governor and White House Ch...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$312,837 to $511,810
Salem, New Hampshire area prices were up 1.6% from a year ago