Director, Regulatory Affairs

Werfen

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.

Job Summary

The Regulatory Affairs Director for Autoimmunity will build and lead a growing Regulatory Affairs team by recruiting, managing, coaching, and developing the team to ensure skills are aligned with a high performing organization. This position will direct the Regulatory team in supporting products (instrumentation, hardware, software, and reagents) over their lifecycle from new product development, market authorization documentation, labeling review, design changes, post market activities including field actions, reportable events, and surveillance. The Director will confirm information and data in support of marketing authorizations, regulatory reports, and post market documentation is complete and accurate to state-of-the-art guidances, standards, and regulations. The position will ensure proactive regulatory intelligence to develop regulatory strategies and implementation plans in collaboration with project teams, affiliates, and distributors to implement regulatory affairs strategies and projects.

Key Accountabilities

• Design Control: Guide cross-functional teams in defining regulatory requirements, identifying regulatory risks then generating, deploying, and implementing corresponding regulatory strategies. Confirm appropriateness of internal evidence of safety and efficacy for acceptability in licensing applications, submissions, and registrations for market authorization in indicated geographies.
• Marketing Authorizations: Provide guidance with input from regulatory bodies and distributing partners on most effective regulatory path for achieving marketing authorization. Lead team to schedule milestones, generate supporting documentation, and provide deliverables for assigned global regulatory applications, registration, licensing, reporting. submissions declarations, attestations, certifications, design dossiers, technical documentation, export certificates, and renewals according to governing rules and regulations of the affected geographies. Oversee the final review of market applications to ensure compliance to regulatory agency standards and requirements for submissions. Represent company in interactions and communications with regulatory authorities. Coordinate with internal personnel to resolve potential regulatory issues, deficiencies, and questions from regulatory agencies.
• On Market Support: Manage team in creation, changes to, review, assessment and maintenance of design changes, product labeling, advertising and promotional materials, design dossiers, technical documentation, regulatory agencies communications, post-market reports, health hazard evaluation, risk-benefit reports, reportable event assessments and filings, and Field Action/FSCA assessments and filings, license application and renewals, and laser reports while ensuring records organized maintained in central repository. Represent company in interactions and communications with regulatory authorities.
• Regulatory Intelligence: Actively participate in trade and professional organizations to maintain current knowledge of applicable regulatory requirements and scientific breakthroughs in the marketed geographies and technologies. Monitor, analyze and develop strategies for new and emerging regulations, guidances, and standards in marketed geographies. Deploy and coordinate plans for establishing and maintaining compliance. Communicate impact on the business or portfolio to senior management.
• Department Management: Educate and broaden the regulatory knowledge of the department and understanding of other functions. Implement regulatory projects to accomplish company goals and initiatives. Recruit, develop, and maintain highly qualified staff, foster staff career development, and provide technical guidance. Mentor, train, set expectations, ensure accountability, and perform evaluations for the Regulatory team. Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities. Support regulatory inspections and third-party audits. Provide back-up support for Regulatory Team. Supervisory and administrative duties such as PTO management. Educates and manages assigned area to ensure compliance with applicable Standard Operating Procedures (SOPs), ISO, FDA, and other applicable Quality Systems regulations, as well as Environmental Health & Safety, Human Resources and other regulatory and administrative policies. Represents the Inova Management team and reflects the company's values as a role model to employees and customers.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Minimum Knowledge & Experience required for the position:

* Bachelor's degree in a life science, engineering, or equivalent required. Advanced degree preferred.* Regulatory Affairs Certification preferred.* Fifteen (15) years of work experience in in vitro diagnostic (IVD) or medical device (MD) industry of which ten (10) should be Regulatory and six (6) in managing regulatory profes-sional teams.* Demonstrated record of accomplishment in obtaining successful marketing authorizations in US and ex-US required.* Experience with post-market surveillance required.* Project management experience preferred.

Skills & Capabilities:* Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.* Advanced ability to mentor, train, and develop skills of staff in regulatory concepts and their implications. * Advanced knowledge of regulatory intelligence tools and methods along with ability to interpret and apply regulations.* Advanced skills in verbal and written communication including scientific writing and presentation.* Advanced skills in leadership, influence, and negotiation with the ability to build collaborative relationships.* Advanced ability to organize and complete multiple assignments in a fast-paced environment in a timely, accurate manner as a team member and/or as an individual contributor.* Advanced ability to develop regulatory strategies that balance short and long-term objectives while adhering to timelines.* Advanced ability to function effectively with ambiguity in a rapidly changing environment while developing proactive and creative approaches to problem solving.* Advanced ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy. * Advanced knowledge and ability to optimize use of electronic tools such as epublishing, salability control databases, and efile management system.

Travel requirements:

Ability to travel up to 10%.

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate.

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $150,000 -$215,000. Individual compensation is based on the candidate's qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com