Regulatory Affairs Subject Matter Expert

Job description

Regulatory Affairs Subject Matter Expert

Your role: To provide regulatory support and leadership to the Livingston manufacturing site product portfolio of IVD and intermediate biologic products and provide subject matter expertise for projects and business support. Manage, plan and implement global product registration and listing activities. Responsible for required regulatory submissions and product registrations/licensing for new products with either directly (for example in EU, US and Canada) or indirectly working with regional regulatory groups and or third-party representatives. Support, plan and implement strategic regulatory projects and initiatives including new product introduction. Act as SME contact with business fields – working with Business to understand support strategy, provide regulatory expertise and advocacy. Responsible for any required regulatory re-certification or annual re-listings, updates and reports for regulated products. Responsible for reviewing change controls relating to regulated products and liaising with regional regulatory organizations to ensure any required regulatory change notifications/reporting or new submissions are carried out. Responsible for reviewing complaints and participating in risk assessments to determine regulatory vigilance requirements. Responsible for carrying out authority vigilance reporting either directly or liaising with regional regulatory groups or third-party representatives to facilitate vigilance reporting. Responsible for regulatory review of document changes, deviations and printed materials as required to ensure all necessary regulatory requirements are met.  Write and maintain procedures relating to the Regulatory management function, the preparation and presentation of quality reports, data and Key Performance Indicators for management reviews. Act as liaison between site and notified body or other regulatory authorities. Surveillance of global regulation impacting IVDs and reporting of changes/new regulations to ensure compliance. Provide regulatory training and support to departments as needed to ensure regulatory requirements as applied to the Company’s product(s) are understood

 

Who you are:

·  A regulatory affair professional with  experience working within the IVD or medical device industry.
·  Undergraduate Degree in a quality or science related discipline (Post graduate degree preferred)
·  Expert knowledge/experience of Medical device/IVD regulations within Europe and North America.
·  Working knowledge of global Medical device/IVD regulations.
·  Experienced, innovative, and motivated with demonstrated leadership skills.
·  Proven track record of participation and leadership within major regulatory projects involving multiple cross-functional departments and 3rd parties.

 

To all recruitment agencies/suppliers: we are lucky enough to receive fantastic applications and have an in house recruitment team. Therefore unless you are formally requested by a member of the in house recruitment team to support us and then given access to our portal you are not engaged to work with Merck. Please do not contact hiring managers directly or send speculative profiles or CVs – we will not accept these as an introduction and you will not be paid any fee or considered for our preferred supplier list.

Equal Opportunities: We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

 

 

Job Requisition ID: 197513

Location: Scotland - all

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Medical, Medical Device, Healthcare