The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Clinical Trials, Cosmetics, Medical Device, Quality/Risk Management
4 Year Degree
The Manager, Regulatory Affairs develops and executes regulatory strategies for new products and lifecycle management of existing products. Acts as primary contact for regulatory on cross functional product development and post-marketing teams and leads submission activities throughout product development and lifecycle.
Regulatory Support for Project/Product Teams
Provide regulatory strategic direction on projects/products.
Identify and assess regulatory risks and project/product issues as well as recommend solutions and strategies to teams and management.
Conduct and analyze regulatory research providing guidance to teams on past precedence, competitive landscape, and recommended regulatory pathways.
Effectively manage project timelines as defined by department, project team, and corporate objectives.
Provide guidance and participate on execution of Product Development Design Control Activities
Provide guidance and participate on Risk Management Activities
Provide guidance on clinical studies
Lead major submission activities.
Plan and prepare regulatory submissions medical device or combination products for new and existing products to ensure the timely approval for clinical and non-clinical studies and marketing applications.
Ensure documents are in compliance with current regulations and guidance.
Sustaining Regulatory Support
Maintenance of establishment registrations and listings
Maintenance of Unique Device Identifier(s)
Provide regulatory input to Quality and Operations functions for post-market project activity, including change control assessments
Work with Commercial and R&D colleagues to develop ‘best in class’ labeling.
Review product labeling for regulatory compliance
Communication with Regulatory Authorities
Primary point of contact for Global Health Authorities. Communicate regulatory requirements to internal stakeholders.
Interact with contract manufacturers, affiliates and distributors.
Maintain current regulatory knowledge of regulations, guidelines, and standards and apply appropriate implementation strategies.
Mentor and provide guidance to junior staff. May manage and supervise direct reports including work assignments and performance feedback, appraisals and reviews.
Provide support to other regulatory staff as needed and perform duties and assignments as required. Communicate and raise questions/issues to the attention of regulatory management. Additional duties as needed to support the business and overall company objectives
BA/BS in scientific or health discipline
Master’s degree preferred
Minimum 5 years relevant regulatory experience
Direct experience with development, preparation and submission of IDE, Original PMA, PMA Supplements (30DN, Real Time Supplements, 180-DS)
Direct experience in Unique Device Identifier Management
Direct experience in FDA Establishment Registrations and Device Listings
Strong knowledge of US Medical Device (Class I, II, III) regulatory environment and FDA regulations and guidance. Class III Medical Device Experience Preferred.
Proficient in all MS Office applications
Proficient in Adobe DC or Adobe Professional applications
Proficient in FDA eSubmitter applications
Demonstrated organizational skills, ability to independently prioritize work and detail oriented
Strong verbal and written communication skills
Good working knowledge of Medical Device/Combination Product FDA regulations
Hands-on Experience with preparation of Regulatory Strategy Assessments
Hands-on Experience with preparation of 510(k), IDE, Original PMA including preparation of electronic submissions
Experience with regulatory/compliance in clinical, non-clinical, manufacturing issues
Demonstrated leadership skills and experience as a team lead is preferred
Excellent interpersonal skills
Employer will assist with relocation costs.
Additional Salary Information: Full benefits package
Internal Number: 001
About Merz Aesthetics
At Merz Aesthetics, our mission – the purpose we bring to our work each and every day – is to improve patient health, helping people all over the world to look better, feel better and live better.
What makes Merz Aesthetics unique? It’s the way we connect, take on challenges and revel in big wins.
Become part of the Merz Aesthetics family and root yourself in our 112 year history of innovation and commitment. Merz Aesthetics offers its employees the opportunity to make an immediate impact and positively enrich the lives of others by exemplifying the foundation built by our founder, Friedrich Merz.
What we are proud to offer:
A diverse and transparent leadership team
Empowerment to grow your career in a way that is meaningful to you
Best in class benefits and competitive compensation
A highly collaborative and supportive work environment
The opportunity to participate in our community and philanthropic events
Our employees share in our values to persist in innovation, commit to customers and colleagues and deliver trusted results. We exist to fuel confidence in every person we touch; confidence in self and confidence in us. We empower individuals in their person...al quests to be their best selves — no matter what that means. Because every person has a unique brand of confidence.
For our customers, patients and employees, we exist to bring authentic confidence to life.