Job Description

A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Regulatory Affairs Specialist role.

Our client, a leading medical device company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you.

Responsibilities include :

1) Responsible for the review, maintenance and monitoring of documentation related to the device's regulatory compliance, such as technical files, design dossiers, and labeling requirements

2) Identify regulatory pathways for initial product designs and provide input to internal stakeholders in preparation of FDA 510 K and De Novo submissions using a risk-based approach

3) Analyze and communicate the adequacy of proposed regulatory pathways and strategy for initial product designs and recommend changes or refinements based on initial regulatory outcomes

4) Write and review regulatory documents with a critical eye for suitability for submissions to the FDA and any other regulatory agencies as needed

5) Handle the preparation of electronic submission packages for regulatory agencies in compliance with applicable requirements and best practices

6) Evaluate regulatory policy and critically assess the impact of changing regulations on pre-approval and post-approval strategies and approach and advise internal stakeholders on a course of action

7) Participate in multidisciplinary project teams within the US Market Access Department providing guidance and direction on current regulatory pathways and expectations

8) Stay current on changes to the regulatory environment that could impact new product submission strategies

9) Work closely with quality assurance and quality control teams to establish and maintain appropriate quality systems for IVDs

10) Establish working relationships and interface with multiple government and non-government organizations having an impact on market access and distribution

11) Identify the need for and manage the development and execution of new regulatory procedures and standard operating procedures

12) Frame issues with a thorough understanding of legislation, regulations, guidance, policy and directives

13) Create work plans with appropriate staging of activities and with clearly defined milestones

14) Remain up-to-date on scientific and clinical advances that impact healthcare product development and assess the relationship to regulation and regulatory issues

15) Provide strategic input and technical guidance on global regulatory requirements to product development teams

16) Work with a document control group to ensure regulatory document archiving

17) Evaluate risks of product and clinical safety issues during clinical phases and recommend regulatory solutions

18) Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and propose plans for changes that do not require submissions

19) Review and assess proposals to regulatory authorities on regulatory paths and clinical plans

20) Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims

21) Participate and lead key negotiations and interactions with regulatory authorities during all stages of the development and review process

22) Establish and maintain business relationships with officials in federal and state government regulatory agencies

23) Perform other related duties as assigned

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory affairs

If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply we want to hear from you!

Compensation and Other Details

Base Salary : Highly competitive package, commensurate with experience

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