Director/Senior Director, Regulatory Affairs
2800 Woods Hollow Rd Fitchburg, WI 53711 US
JOB OBJECTIVE: Responsible for leading the overall Regulatory Affairs strategy and direction (premarket, adverse event reporting, recalls, regulatory policy and advocacy for the US and worldwide). Translates strategy into tactics, priorities, and resource requirements for execution of plan to assure successful implementation and ultimate success. A focus on overall team development is imperative for success in this position. Lead the regulatory affairs teams in delivering world-class regulatory service to the business by creating and supporting a regulatory compliant culture by providing advice and counsel to business managers.
1. Maintain a high degree of knowledge and awareness of the external environment and work with external associations & global regulatory bodies to remain current. Proactively adapt regulatory strategies and influence change within areas of responsibility.
2. Identify regulatory trends in the region and their implications, taking into consideration the impact on business decisions.
3. Ensure compliance with applicable regulations (US FDA QSRs, Europe IVDD/IVDR, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
4. Manage global registrations with internal and/or external resources.
5. Analyze and communicate proposed, new, or changing requirements, lead teams to develop strategies to implement and sustain compliance requirements. Oversee all programs and processes to meet business objectives and ensure compliance with regulatory requirements.
6. Evaluate performance metrics to identify program opportunities, recommend and initiate improvements in procedures or oversight.
7. Mentor, coach and teach direct and indirect reports on activities within areas of responsibility. Effectively manage the recruitment, development, training, and performance management of direct reports.
8. Educate, train, advise and coach company professionals among cross functional teams to ensure compliance with RA requirements.
9. Work collaboratively with other departments, managers, and staff throughout all branches to ensure a consistent approach to regulations is adopted throughout the business.
10. Lead and support continuous improvement activities regarding areas of responsibility.
11. Represent company in interaction with regulatory agencies.
12. Contact customers directly about quality issues or questions as directed.
13. Organize and implement training programs in areas of Regulatory Affairs.
14. May lead and/or direct other areas related to Quality Systems, e.g., CAPA, Nonconforming, Internal Audit as needed.
15. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
16. Embracing and being open to incorporating our 6 Emotional & Social Intelligence (ESI) core principles in daily work.
17. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. MS Degree in a science or engineering related field or equivalent work experience.
2. 20+ years of Regulatory experience in the medical device industry.
3. 10+ years of leadership experience, including training and coaching team members.
4. Expert knowledge and experience applying global device laws & regulations for product registration, adverse event reporting, & recalls.
5. Class I, II and III medical device experience. Experience with CDx products a plus.
6. Experience in PMA, 510K submissions, including leading resubmission meetings with the FDA.
7. Regulatory Affairs Certified (RAC).
8. Demonstrated ability to lead cross-functional teams.
9. Advanced knowledge and experience managing regulatory issues and interfacing with local and international regulatory bodies, such as FDA, European competent authorities and notified bodies, Health Canada, SFDA, KFDA, etc.
10. Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals.
11. Demonstrated experience operating in a highly regulated environment.
12. Excellent verbal and written communication and presentation skills with the ability to influence and make recommendations at all levels of the company.
1. Experience supporting IVD products.
2. Experience in supporting regulatory strategy for CDx products.
1. Visual acuity required for physical inspection of finished product and raw materials and accompanying documentation.
2. Ability to travel internationally and domestically as needed.
3. Able to utilize computer hardware and software including Microsoft Office and other commonly used information systems.
Salary Range: $200-$235k. Salary will be commensurate with experience
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