Location: Fort Lauderdale, FL
Company: Orchestra Biomed
to drive successful global commercialization of products it develops. Orchestra Bio Med is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team.
Its flagship product candidates are Back Beat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra Bio Med has a strategic collaboration
with Medtronic for the development and global commercialization of Back Beat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.
Scope and Purpose Orchestra is seeking an experienced Regulatory Submissions and Operations Manager to support global regulatory filings and processes and management of regulatory documentation. This role will liaise with other functions, provide input into regulatory expectations for submission activities, manage submission deliverables and timelines, draft needed regulatory content,
and create and manage regulatory documentation repositories, and collaborate with internal and external cross-functional teams.
The person in this roll will be based in the Ft. Lauderdale, FL office. Role and Responsibilities – Including but not limited to: Supports preparation of submission content, including working with regulatory leadership to develop submission plans (authoring, review, publishing, and timelines) for clinical and commercial applications, such as pre-submissions, IDEs, master files, and/or PMAs. Guides the authoring and review of submission content by relevant technical experts (internal and external) and contributes to the authoring and review of submission sections, as needed.
Critically review documents for consistency and quality, identifying gaps in supporting documentation, and make technical/grammatical edits, as necessary. Actively collaborates with internal and external stakeholders, including Device and medical Development, Quality, CROs, CMOs, and consultants. Acts as a liaison between submission stakeholders in order to ensure timely submission of compliant and high-quality regulatory documents. Ensure that the regulatory records in internal documentation systems are accurate and complete. Will contribute to development of new internal processes and SOPs as necessary, including improvement of regulatory documentation systems.
Qualifications – Knowledge & Skills: Bachelor's degree preferred 2+ years experience in Regulatory Affairs, with focus on regulatory submissions and documentation management. Experience in medical/technical writing for regulatory submissions will be considered. Experience in regulatory submissions for medical devices with additional experience in the use of FDA’s electronic submission portals and templates is a plus. Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions.
Experience in submission of master files and/or drug content, particularly in CTD format, is a plus. Experience in project management a plus. Contribute to the development of standards, templates, and procedures related to regulatory submission and documentation management. Strong writing, communication, and interpersonal skills with the ability to effectively work both independently and in an interdisciplinary team. Critical thinker with excellent attention to detail Ability to manage multiple tasks and coordinate submission deliverables from multiple internal and external stakeholders.
Takes responsibility for actions and results and works with honesty and integrity. Basic computer proficiency, including Microsoft Office suite and virtual meeting tools (e. g. Teams) Candidates must be authorized to work in the US now and in the future. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. The level of this position will be based on the final candidate’s qualifications.
All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. EQUAL OPPORTUNITY EMPLOYER Orchestra Bio Med is committed to non-discrimination with respect to race, creed, color, religion, age, disability, interaction, interactionual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
Orchestra Bio Med has a multi-part and competitive compensation structure: Competitive base salary based on experience Annual bonus based on exceptional company and individual performance Equity grants appropriate for role We offer a comprehensive and competitive benefits package which includes health, dental, and vision, 401k as well as other benefits. Our Vision To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships. Our Mission We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners and stakeholders.
Our Values We care about patients, physicians, partners, and each other We are creative , open-minded, adaptable and think “outside the box” We are driven to always do our best and we do not give up We deliver and are accountable to promised results Important notice to employment businesses/agencies Orchestra Bio Med does not accept referrals from employment agencies unless written authorization from the Orchestra Bio Med Human Resources department has been provided.
In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra Bio Med will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra Bio Med.
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