Director, Regulatory Affairs (Transfusion)

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

The Director, Regulatory Affairs is responsible for leading the day-to-day activities of Regulatory Affairs with specific emphasis on global regulatory submission strategy, regulatory submissions, adverse event reporting / field actions, and interaction with global regulatory authorities related to Werfen Transfusion portfolio. The Director, Regulatory Affairs provides direct regulatory support for multiple Transfusion projects within the Transfusion Technology Center.

Key Accountabilities

• Lead the overall strategy development, implementation, and coordination of regulatory affairs activities for Werfen Transfusion Technology Center. Ensure alignment of regulatory strategy to business strategy across all functional areas.
• Assess regulatory pathways and oversee the development of global regulatory strategic plans and regulatory submissions (IND/BLA/TDF/OUS Dossier) required to obtain registration for new Transfusion products under development and throughout the product's life cycle.
• Create, prepare, and submit organized and scientifically valid regulatory submissions in the US (IND, BLA, and 510(k), EU (TDF), and assist with OUS (submissions to Regulatory Authorities, and Notified Bodies).
• Manage and organize the Regulatory Affairs department ensuring that departmental objectives are implemented in line with the overall Q&R / Werfen Transfusion Corporate goals, and within Regulatory Affairs department FY budget.
• Provide guidance to Regulatory Affairs staff who participate on project teams and provide regu-latory advice and direction to ensure complete and scientifically sound product submissions.
• Provide guidance and regulatory input to various functional groups within the company to ensure optimal development of market access strategies.
• Responsible for monitoring, interpreting, and implementing current and new regulatory require-ments for US, EU, and ROW. Interact directly with regulatory authorities and represent the company in dealing with regulatory agencies on defined matters. Serves as liaison between the Company and the regulatory au-thority for specific product submissions and/or compliance activities.
• Determine an event's reportability to FDA under the Medical Device Reporting System (MDR), and to Competent Authorities for EU/EEA and Canada under Medical Device Vigilance System (MDV).
• Determine an event's reportability to FDA under the Biological Product Deviation Reporting (BPDR).
• Performs other duties and responsibilities as assigned
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Minimum Knowledge and Experience

Education:

Bachelor's degree in science, engineering or related field required.

Advanced degree preferred.

Experience:

Minimum of 10 years progressively responsible US, EU, and international regulatory affairs experience in a medical device industry required.

Minimum of seven (7) years of people-management experience.

BLA and/or Class III device, clinical study, and hands-on advanced quality systems experience are required.

Skills and Capabilities:

• Sophisticated knowledge of and experience with FDA medical device and biologics regulations and guidance, Regulation (EU) 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 13485 Quality System standards, ISO 14971 Risk Management, and other applicable US and international regulations, guidances, and standards required.
• Successful experience with the origination of 510(k), IND, and/or BLA submissions also re-quired.
• Must have experience in setting up/supporting multicenter medical device clinical trials, clinical FDA audits (BIMO), quality system development/implementation and both internal and 3rd party/FDA audits.
• Create strong, effective working relationships with the FDA and outside consultants.
• Instill a proper degree of discipline and quality.
• Provide product regulatory direction to product development teams to achieve successful prod-uct introductions.
• Work effectively with all levels of staff.
• Communicate regulatory requirements and issues effectively within the Company, and with out-side agencies and customers.
• High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint required. Visio skills desirable.
• Superior writing, composition, English grammar skills a must.
• A proven record of consistently following through on commitments. Maintains and communi-cates realistic schedules and meets or beats deadlines.
• A service-oriented approach, flexible and proactive towards changing needs. Exceptionally team focused and actively contributes to a positive and innovative work environment.
• Works precisely according to procedures, rules and regulations, has a passion for continuous im-provement and quality.
• Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

Travel requirements:

Approximate percentage of travelling time: 30%

People Manager Core Competencies:

• Building Talent Planning and supporting the development of individuals' knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively.
• Customer Focus Ensuring that the internal or external customer's perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities; crafting and implementing service practices that meet customers' and own organization's needs; promoting and operationalizing customer service as a value.
• Decision Making Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.
• Driving for Results Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
• Driving Innovation Creating an environment (culture) that inspires people to generate novel solutions with measurable value for existing and potential customers (internal or external); encouraging experimentation with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions.
• Emotional Intelligence Essentials Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others' emotions and behavior; leveraging insights to effectively manage own responses so that one's behavior matches one's values and delivers intended results.