SUMMARY: Senior Regulatory Affairs Specialist will be responsible for developing regulatory strategies for moderate to highly complex submissions to US FDA and/or international regulatory agencies; providing risk assessments of strategies and regulatory options to business teams and to product development/support teams; executing regulatory product submissions from the strategic planning stages through conduct/completion of clinical trials, submission to regulatory agencies and post-market activities, as required; exercising considerable latitude in determining the manner in which to most efficiently organize activities to complete these submissions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Maintain current knowledge of relevant regulations, including proposed and final rules; Interpret regulatory/compliance policies and guidance and correctly apply them as regulatory activities, and guide in these activities; Interpret statutes, regulations, policies and guidance documents for business teams and product development/support teams. Communicate impact to product development, manufacturing, and/or marketing teams.
Assist Regulatory leadership to develop, maintain, and execute domestic and international regulatory strategies to ensure the business is positioned to meet strategic corporate goals.
Assess regulatory pathways for new product platforms and product modifications; develop regulatory strategies and tactical plans for submissions to US FDA and international regulatory agencies; Identify and communicate potential risks and risk mitigation strategies to stakeholders;
Manage planning and preparation of regulatory submissions (510(k), Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international regulatory agencies, including submissions for pre- and post-market requirements. Ensure regulatory submissions are prepared and processed in a proactive, expeditious and timely manner; Accountable for establishing, maintaining, adjusting and communicating regulatory submission deadlines to ensure that all product-launch related functional area activities can be planned accordingly.
Represent the business in interactions with regulatory authorities. Play a prominent role in complex negotiations regarding clinical and analytical study designs during the product development (pre-submission) phase, as well as the appropriateness of product claims, wording, and interpretation/presentation of performance during the verification/validation (pre-clearance/approval) phase.
Participate on cross-functional product development teams representing the Regulatory Affairs function; Assist in the planning and design of internal studies (including feasibility studies), clinical studies and post-market studies in support of US FDA and international regulatory submissions.
Execute the regulatory review of labels, labeling, advertising and promotional materials; Review labeling/promotional/advertising materials, and other documents to ensure compliance.
Develop policies and procedures which provide direction to the business on regulatory processes and requirements in support of product development.
Remain current on regulatory issues/trends affecting the Company’s products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business.
Provide training to cross-functional teams on a various regulatory issues and processes.
Act as a mentor to other junior Regulatory Affairs associates, participating in development discussions and assisting other associates with developmental tasks and projects.
Maintain proactive and positive working relationships with internal and external customers, both US and ex-US, to ensure the business is positioned to meet strategic corporate goals.
Independently manage and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision.
Other Duties as assigned.
QUALIFICATIONS: The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities in the area of physical demands and work environment. Bachelor’s Degree (BA/BS) from a four-year College or University in a technical, regulatory, engineering and/or scientific discipline or equivalent regulatory/scientific experience; Advanced degree and/or RAC certification preferred.
Minimum 5-8 years of directly related regulatory experience in the medical device (Class II or III) arena.
Solid knowledge of medical device regulations, 510(k) and/or Premarket Approval (PMA) process. Demonstrated success preparing, filing and completing (including internal and external negotiations) regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation). Experience with US FDA Class II/III medical device submissions.
Experience working directly with FDA, notified bodies and/or international health authorities.
Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
Experience analyzing complex issues and formulating cogent approaches to resolving/addressing issues.
Bachelor’s Degree (BA/BS) from a four-year College or University in a technical, regulatory, engineering and/or scientific discipline or equivalent regulatory/scientific experience; Advanced degree and/or RAC certification preferred
Internal Number: SRRA
About Bovie Medical Corporation
Bovie Medical Corporation is a leading maker of medical devices and supplies as well as the developer of J-Plasma® (marketed and sold under the Renuvion™ Cosmetic Technology brand in the cosmetic surgery market), a patented plasma-based surgical product for cutting, coagulation and ablation of soft tissue. J-Plasma/Renuvion technology utilizes a helium ionization process to produce a stable, focused beam of plasma that provides surgeons with greater precision, and minimal invasiveness. The new J-Plasma/Renuvion handpieces with Cool-Coag™ technology deliver the precision of helium plasma energy, the power of traditional monopolar coagulation and the efficiency of plasma beam coagulation - enabling thin-layer ablation and dissection and fast coagulation with a single instrument, minimizing instrument exchange and allowing a surgeon to focus on their patient and their procedures. With Cool-Coag technology, the new J-Plasma/Renuvion handpieces can deliver three distinctly different energy modalities - further increasing the utility and versatility of the system. Bovie Medical Corporation is also a leader in the manufacture of a range of electrosurgical products and technologies, marke...ted through both private labels and the Company’s own well-respected brands (Bovie®, IDS™ and DERM™) to distributors worldwide. The Company also leverages its expertise through original equipment manufacturing (OEM) agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Bovie Medical Corporation website at www.boviemedical.com.