Senior Regulatory Affairs Manager (f/m/x)

About us

Zimmer Biomet is one of the leading international companies in the field of medical technology. Together with more than 18,000 people worldwide we deliver medical implants to more than 100 countries. Our products and solutions restore mobility, alleviate pain and improve the quality of life for patients around the world.

Our innovations helps treat disorders of, or injuries to, the bones, joints and supporting soft tissues. Together with healthcare professionals, we help millions of people to live better lives.

It’s our promise to look beyond what’s possible now and discover what’s possible next and to help healthcare professionals and their patients progress to the next level. Every day, we focus on improving musculoskeletal healthcare. 

Our Mission is to alleviate pain and improve the quality of life around the world.

Principal Duties and Responsibilities

• This position is responsible for providing regulatory support to develop and market Zimmer products.
• The function is responsible for developing regulatory submission strategies, registration dossiers and managing departmental projects, supervising development of or creating and reviewing labeling, providing guidance and consultation for EU, US and international regulations,
• Interacting with regulatory agencies, and certification bodies.
• Regulatory background should include the medical device area, and preferably orthopedic experience.
• May mentor and train junior team members
• Direct impact of work output and through the provision of regulatory advice/counsel related to related to business or technology.

New Product Development

• Advise New Product Development teams when developing new products to define regulatory requirements for Europe and international markets
• Prepare the technical documentation for the Conformity assessment of products
• Support and participate (as necessary) in the development of the information for use and package inserts, evaluation of promotional and advertising material for compliance with applicable regulations
• Provide guidance (interpretation) of RA relevant standards, guidance documents and regulations
• Support design examination submissions to the notified body
• Author 510(k) submissions and support interactions with FDA

Post Market Engineering

• Review proposed product and process changes for impact on regulatory status of product
• Support of Post Market Surveillance activities

International registrations

• File submissions to international authorities (compile required documentation) for Zimmer Biomet products and interacts directly with competent authorities or with Zimmer entities

Custom Made devices

• Perform conformity assessment of custom made devices according to the applicable regulations

Various

• Support of external Audits (Authorities, Notified Body)
• Implement RA relevant regulations into QMS procedures
• Work with the RA team to keep all areas of Zimmer informed of regulatory requirements and emerging
  issues which may affect the registration approval of products
• Coach RA employees, and may be responsible for RA training on the job 

Expected Areas of Competence

Personal skills requirements

• Strong written and verbal communication skills including presentation skills.
• Sound and comprehensive communication and diplomacy skills are required in order to achieve internal and external customer satisfaction
• Ability to independently handle regulatory assignments of any complexity
• Ability to identify and assess business risks for a given regulatory strategy.
• Ability to lead regulatory aspects of projects as a core team member and ability to establish buy-in from other team members.
• Ability to plan work in a systematic way by identifying and organizing all activities, including those of other functional areas, into time-dependent sequencing with realistic but aggressive timelines.
• Resolve problems by identifying and applying solutions from acquired experience and will be guided by precedents.
• Ability to understand the effect his/her actions on the team or project

Education/Experience Requirements

Education

• MAS (Master of Advanced Studies) or equivalent
• University Degree (BSc) or equivalent in life sciences, technical (engineering) or related field. (Equivalent to Fachhochschule Abschluss)
• Advanced University Degree (Msc) or equivalent in life sciences, technical (engineering) or related field preferred

Professional experience

• Significant experience, typically 4-6 years, in a regulated industry, preferably in orthopedics if the candidate has a MAS title or equivalent
• Typically 3 - 5 years Regulatory Affairs experience in medical device industry if the candidate has a BSc title or equivalent
• Good computer skills, including Microsoft Office Suite

Special expertise

• Working knowledge of and experience applying EU & US medical device regulations and guidance documents

Languages

• Fluency in English both verbal and written
• Basic German both verbal and written

Travel Requirements

• Up to 10%