Sr Regulatory Affairs Spec

Planet Pharma; Jacksonville (FL); Vor Ort; USD 104.000 - 125.000; Vollzeit

Zusammenfassung

Planet Pharma in Jacksonville, FL seeks an experienced regulatory professional to manage 510(k) and EU MDR submissions with a strong ownership mindset. The role emphasizes cross-functional coordination and effective interaction with regulatory authorities.

Requirements include a Bachelor’s degree in a scientific discipline and 5–8 years in medical device regulation. This is a full-time role; on-site preferred with potential remote consideration based on experience.

Qualifikationen

• Bachelor’s degree in a scientific discipline or equivalent.
• 5–8 years of regulatory experience in medical devices.
• Experience with 510(k) and EU MDR submissions and strategy.
• Knowledge of IEC 60601 regulatory requirements.

Aufgaben

• Directs or coordinates document packages for regulatory submissions from all areas of the company.
• Leads or compiles materials required in submissions, license renewals and annual registrations.
• Recommends changes for labeling, manufacturing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking/control systems and interfaces with regulatory agencies as needed.
• Recommends strategies for earliest possible approvals of clinical trial applications.

Kenntnisse

Regulatory submissions

IEC 60601 experience

Cross-functional communication

Ownership

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

Pay 50-60/h depending on experience

HM’s Top Needs:

1. 510k and EU MDR writing submissions – strategy

2. experience with electrical medical device IEC 60601

3. strong ownership, communication, and cross-functional skills

Education Required: Bachelor’s degree in a scientific discipline or equivalent

Years’ Experience Required: 5-8 years

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes 40 hours per week

Work Location: Jacksonville, FL is preferred; however, remote candidates may be considered based on experience.

Does this person need to be on site? If so, full time or part time? Full time

Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation – while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others’ work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.