Regulatory Affairs Sr. Specialist (608352)

Job content

Job Summary

Looking to make an impact? Join Us and make the difference.

Zimmer Biomet is a leading global healthcare business whose innovations treat patients with disorders or injuries that affect bones, joints or supporting soft tissues. Our mission is to Alleviate pain and improve the quality of life around the world; and to achieve this, we’re investing significantly in new technology and processes to transform our ways of working and unlock greater growth potential in ourbusiness.

• 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.
  

Principal Duties and Responsibilities

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 GmbH products and interacts directly with competent authorities or with Zimmer entities
  

Post Market Engineering

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

International registration

• File submissions to international authorities (compile required documentation) for Zimmer GmbH 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
  

Why work with us?

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. This is your opportunity to do rewarding work, feel part of a higher purpose and to be recognised for your contribution.

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
  

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