Director Of Regulatory Affairs Jobs in Indiana

Job Title: GROUP MANAGER REGULATORY AFFAIRS Company: Beckman Coulter Location: Indianapolis, IN Description: Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Instruments for life science research are used by scientists as they study complex biological problems including the causes of disease, identify new therapies, and test new drugs. Our customers include hospitals, physicians offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has more than 200,000 clinical and research instrument systems operating in laboratories around the world. Job Description: The Group Manager Regulatory Affairs oversees, directs and controls regulatory compliance programs for specific development centers or business units. The incumbent provides direction and ensures regulatory projects are completed within projected costs and schedules; is the regulatory resource regarding regulatory policy and practices for development center teams for specific sites; develops and implements advanced and aggressive regulatory strategies that provide a competitive edge to the development center in new and modified product commercialization and in the management of regulatory compliance activities; ensures site business teams consider the impact of current or emerging regulatory issues; works with site management to facilitate and ensure company practices are consistent with the corporate regulatory risk posture. Develops resourcing strategies, allocates budgets, staff, tools, and specialized support necessary for cost-effective operations. Responsible for hiring/firing/disciplinary decisions affecting employees. Recommends or terminates external resources (contractors). Participates in departmental, division, corporate strategic and tactical planning processes. Communicates Regulatory Affairs status, issues to executive management, users and staff. Adheres to policies and procedures. Requirements: Bachelors degree required; prefer an engineering or science background 8-10+ years of relevant experience; minimum 4-5 years in Quality Managing an organization to ISO 13485 and FDA cGMP requirements in a warehouse and distribution environment Supervisory experience preferred ISO Lead Auditor Certification a big plus Ability to work in matrix environment and be able to manage by influence If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com. AN EQUAL OPPORTUNITY EMPLOYER - We believe that the mutual goals of our business and the community can best be met through our policy that consideration of race, color, religion, ancestry, national origin, sex, age, disability, veteran status or other protected characteristics, has no place in the selection, training or promotion of employees. In furtherance of this policy, we have developed a written Affirmative Action program to ensure positive action in providing equal opportunity for employees and applicants. Apply Online: https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetail&ccid=bupJEdUjsTs=&job_REQUISITION_NUMBER=75820

Job Title: Regulatory Affairs Manager Company: Depuy Products Inc. (6030) Location: Warsaw, IN Description: DePuy Orthopaedic, a member of Johnson & Johnson's Family of Companies, is recruiting for aRegulatory Affairs Manager located in Warsaw, Indiana. DePuy is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from degenerative diseases, deformities, trauma and sports related injuries. Our environment is entrepreneurial, learning-driven, and as challenging as it is rewarding. The Regulatory Affairs Manager has responsibility for managing the Regulatory Submissions team and budget. Will be responsible for developing US and International regulatory strategies and interfacing with regulatory agencies and marketing/engineering regarding strategies and submissions. Responsible for independently preparing and submitting regulatory submissions for the US, including 510(k)s, PMAs, PMA supplements, IDEs, minor modifications. Will prepare original technical files, design dossiers, technical file revisions, STEDs and other documents for the Global market. Also responsible for reviewing all submissions prepared by the Regulatory Submissions group. Will review labeling and advertising to ensure compliance with FDA regulations. Performs all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. The Regulatory Affairs Manager will know, understand, incorporate and comply with all applicable laws and regulations relating to DePuy's business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. Will obtain approval of new products and regulatory support for marketed products, provides guidance and interpretation of global regulatory requirements to help ensure efficient use of product resources, and oversees responses to regulatory questions and correspondence. Will manage and/or prepare regulatory submissions and files, including 510(k)s, PMAs, PMA supplements, IDEs, Minor Modifications, technical files, design dossiers, technical file revisions, STEDs and other documents international submissions. Interacts with regulatory agencies to resolve matters and expedite the approval process, provides regulatory guidance to project teams, evaluates product and process changes and deviations for regulatory compliance, and conducts labeling and advertising review. Will administer budget, performance reviews and development planning for staff.QualificationsA minimum of a Bachelor's degree in biological sciences, bioengineering and/or related medical/health fields is required. A minimum of 8+ years experience in medical device regulatory affairs in a regulated healthcare environment or industry is required. A minimum of3+ years supervisory experience is required. Pharmaceutical and/or Biologic experience a plus. Experience being responsible for independently preparing and submitting regulatory submissions for the US is required. Experience in writing 510(k)s, PMAs, PMA supplements, minor modifications, design dossiers, technical file revisions, STEDs and other documents for the Global market required. IDE experience is an asset. European Medical Device Directives knowledge required.Above average oral and written communication skills employing tact and diplomacy and tactical regulatory and business knowledge to gain approval and ensure maintenance of legal marketing status of all products will be needed. Broad-based technical knowledge and skills in diverse areas of business (e.g., R&D, Operation, Marketing, etc.) are an asset. The ability to effectively negotiate and influence peers, affiliates and regulatory agencies to ensure that regulatory and business needs are met will be needed. Demonstrated leadership ability as well as demonstrated high level of ethics in concert with Johnson & Johnson (J&J) Credo and other J&J and DePuy corporate policies will be needed.